UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, ~~2022~~2023


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE TRANSITION PERIOD FROM TO

Commission file number: 001-36912

CIDARA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

46-1537286

(State or Other Jurisdiction of

Incorporation or Organization)

(I.R.S. Employer

Identification No.)

6310 Nancy Ridge Drive,

Suite 101

San Diego,

92121

(858)

752-6170

(Address of Principal Executive Offices, including Zip Code)

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, Par Value $0.0001 Per Share

CDTX

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer

☐

Accelerated filer

☐

Non-accelerated filer

☒

Smaller reporting company

☒

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of October 31, ~~2022,~~2023, the registrant had ~~71,618,091~~90,433,777 shares of Common Stock ($0.0001 par value) outstanding.

CIDARA THERAPEUTICS, INC.

TABLE OF CONTENTS


PART I. FINANCIAL INFORMATION		3
	Item 1. Condensed Consolidated Financial Statements (unaudited)	3
	Condensed Consolidated Balance Sheets as of September 30, ~~2022~~2023 (unaudited) and December 31, ~~2021~~2022	3
	Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, ~~2022~~2023 and ~~2021~~2022 (unaudited)	4
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, ~~2022~~2023 and ~~2021~~2022 (unaudited)	5
	Condensed Consolidated Statements of Changes in Convertible Preferred Stock and ~~Stockholders’~~Stockholders ’ Equity (Deficit) for the three and nine months ended September 30, ~~2022~~2023 and ~~2021~~2022 (unaudited)	6
	Notes to Condensed Consolidated Financial Statements (unaudited)	8
	Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	2628
	Item 3. Quantitative and Qualitative Disclosures about Market Risk	3746
	Item 4. Controls and Procedures	3746
PART II. OTHER INFORMATION		3747
	Item 1. Legal Proceedings	3947
	Item 1A. Risk Factors	3947
	Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	7684
	Item 3. Defaults Upon Senior Securities	7784
	Item 4. Mine Safety Disclosures	7784
	Item 5. Other Information	7784
	Item 6. Exhibits	7885
SIGNATURES		7986

PART I. FINANCIAL INFORMATION

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

CIDARA THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets


		September 30, 2022		December 31, 2021			September 30, 2023		December 31, 2022
(In thousands, except share and per share data)	(In thousands, except share and per share data)	(unaudited)				(In thousands, except share and per share data)	(unaudited)
ASSETS	ASSETS					ASSETS
Current assets:	Current assets:					Current assets:
Cash and cash equivalents	Cash and cash equivalents	$	53,078	$	59,680	Cash and cash equivalents	$	48,670	$	32,731
Restricted cash		—		2,593

Accounts receivable	Accounts receivable	5,042		5,356		Accounts receivable	2,855		5,833
Inventory						Inventory	2,467		—
Prepaid expenses and other current assets	Prepaid expenses and other current assets	5,779		4,069		Prepaid expenses and other current assets	3,712		6,530
Total current assets	Total current assets	63,899		71,698		Total current assets	57,704		45,094
Property and equipment, net	Property and equipment, net	173		256		Property and equipment, net	580		222
Operating lease right-of-use asset	Operating lease right-of-use asset	1,491		2,287		Operating lease right-of-use asset	4,131		1,205
Other assets	Other assets	1,295		1,084		Other assets	1,053		1,072
Total assets	Total assets	$	66,858	$	75,325	Total assets	$	63,468	$	47,593

LIABILITIES AND STOCKHOLDERS' EQUITY
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)						LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:	Current liabilities:					Current liabilities:
Accounts payable	Accounts payable	$	4,244	$	1,301	Accounts payable	$	3,661	$	1,447
Accrued liabilities	Accrued liabilities	8,162		10,198		Accrued liabilities	11,772		7,672
Accrued compensation and benefits	Accrued compensation and benefits	4,117		4,859		Accrued compensation and benefits	4,457		4,922
Current deferred revenue		15,249		13,920
Current contract liabilities						Current contract liabilities	14,679		14,614
Current portion of lease liability	Current portion of lease liability	1,277		1,148		Current portion of lease liability	1,051		1,317
Current portion of term loan		—		2,591

Total current liabilities	Total current liabilities	33,049		34,017		Total current liabilities	35,620		29,972
Long-term deferred revenue		24,398		18,413
Lease liability		344		1,322
Long-term contract liabilities						Long-term contract liabilities	16,504		20,525
Long-term lease liability						Long-term lease liability	3,306		—
Total liabilities	Total liabilities	57,791		53,752		Total liabilities	55,430		50,497
Commitments and contingencies	Commitments and contingencies					Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2022 and December 31, 2021:
Series X Convertible Preferred Stock, $0.0001 par value; 4,947,759 shares authorized at September 30, 2022 and December 31, 2021; 1,870,713 shares issued and 1,818,472 shares outstanding at September 30, 2022 and December 31, 2021		—		—
Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2022 and December 31, 2021; 71,181,197 shares issued and outstanding at September 30, 2022 and 67,863,674 shares issued and outstanding at December 31, 2021		7		7
Stockholders’ equity (deficit):						Stockholders’ equity (deficit):
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2023 and December 31, 2022:						Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2023 and December 31, 2022:
Series X Convertible Preferred Stock, $0.0001 par value; 4,947,759 shares authorized at September 30, 2023 and December 31, 2022; 2,156,713 shares issued and 2,104,472 shares outstanding at September 30, 2023; 1,870,713 shares issued and 1,818,472 shares outstanding and December 31, 2022						Series X Convertible Preferred Stock, $0.0001 par value; 4,947,759 shares authorized at September 30, 2023 and December 31, 2022; 2,156,713 shares issued and 2,104,472 shares outstanding at September 30, 2023; 1,870,713 shares issued and 1,818,472 shares outstanding and December 31, 2022	—		—
Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 90,415,944 shares issued and outstanding at September 30, 2023 and 72,470,440 shares issued and outstanding at December 31, 2022						Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 90,415,944 shares issued and outstanding at September 30, 2023 and 72,470,440 shares issued and outstanding at December 31, 2022	9		7
Additional paid-in capital	Additional paid-in capital	402,649		398,733		Additional paid-in capital	432,315		404,055
Accumulated deficit	Accumulated deficit	(393,589)		(377,167)		Accumulated deficit	(424,286)		(406,966)
Total stockholders' equity		9,067		21,573
Total liabilities and stockholders' equity		$	66,858	$	75,325
Total stockholders’ equity (deficit)						Total stockholders’ equity (deficit)	8,038		(2,904)
Total liabilities and stockholders’ equity (deficit)						Total liabilities and stockholders’ equity (deficit)	$	63,468	$	47,593

See accompanying notes.

CIDARA THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(unaudited)


		Three Months Ended September 30,				Nine Months Ended September 30,					Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands, except share and per share data)	(In thousands, except share and per share data)	2022		2021		2022		2021		(In thousands, except share and per share data)	2023		2022		2023		2022
Revenues:	Revenues:									Revenues:
Collaboration revenue	Collaboration revenue	$	40,744	$	7,076	$	54,069	$	42,347	Collaboration revenue	$	11,250	$	40,744	$	44,854	$	54,069
Product revenue										Product revenue	1,468		—		1,468		—
Total revenues	Total revenues	40,744		7,076		54,069		42,347		Total revenues	12,718		40,744		46,322		54,069
Operating expenses:	Operating expenses:									Operating expenses:
Cost of product revenue										Cost of product revenue	387		—		387		—
Research and development	Research and development	20,041		20,505		55,462		54,074		Research and development	17,330		20,041		53,180		55,462
General and administrative	General and administrative	5,780		4,607		15,058		13,758		General and administrative	3,556		5,780		11,164		15,058
Total operating expenses	Total operating expenses	25,821		25,112		70,520		67,832		Total operating expenses	21,273		25,821		64,731		70,520
Income (loss) from operations	Income (loss) from operations	14,923		(18,036)		(16,451)		(25,485)		Income (loss) from operations	(8,555)		14,923		(18,409)		(16,451)
Other income (expense):
Interest income (expense), net		55		(47)		29		(179)
Total other income (expense), net		55		(47)		29		(179)
Other income, net:										Other income, net:
Interest income, net										Interest income, net	613		55		1,468		29
Total other income, net										Total other income, net	613		55		1,468		29
Net income (loss) before income tax expense										Net income (loss) before income tax expense	(7,942)		14,978		(16,941)		(16,422)
Income tax expense										Income tax expense	(230)		—		(379)		—
Net income (loss) and comprehensive income (loss)	Net income (loss) and comprehensive income (loss)	14,978		(18,083)		(16,422)		(25,664)		Net income (loss) and comprehensive income (loss)	(8,172)		14,978		(17,320)		(16,422)
Allocation of earnings to participating securities	Allocation of earnings to participating securities	(3,081)		—		—		—		Allocation of earnings to participating securities	—		(3,081)		—		—

Net income (loss) attributable to common stockholders	Net income (loss) attributable to common stockholders	$	11,897	$	(18,083)	$	(16,422)	$	(25,664)	Net income (loss) attributable to common stockholders	$	(8,172)	$	11,897	$	(17,320)	$	(16,422)
Basic net earnings (loss) per common share	Basic net earnings (loss) per common share	$	0.17	$	(0.37)	$	(0.24)	$	(0.53)	Basic net earnings (loss) per common share	$	(0.09)	$	0.17	$	(0.20)	$	(0.24)
Diluted net earnings (loss) per common share	Diluted net earnings (loss) per common share	$	0.17	$	(0.37)	$	(0.24)	$	(0.53)	Diluted net earnings (loss) per common share	$	(0.09)	$	0.17	$	(0.20)	$	(0.24)

Shares used to compute basic net earnings (loss) per common share	Shares used to compute basic net earnings (loss) per common share	70,217,985		49,533,956		69,170,865		48,402,095		Shares used to compute basic net earnings (loss) per common share	90,287,441		70,217,985		86,390,446		69,170,865
Shares used to compute diluted net earnings (loss) per common share	Shares used to compute diluted net earnings (loss) per common share	88,592,568		49,533,956		69,170,865		48,402,095		Shares used to compute diluted net earnings (loss) per common share	90,287,441		88,592,568		86,390,446		69,170,865

See accompanying notes.

CIDARA THERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows

(unaudited)


		Nine Months Ended September 30,					Nine Months Ended September 30,
(In thousands)	(In thousands)	2022		2021		(In thousands)	2023		2022
Operating activities:	Operating activities:					Operating activities:
Net loss	Net loss	$	(16,422)	$	(25,664)	Net loss	$	(17,320)	$	(16,422)
Adjustments to reconcile net loss to net cash used in operating activities:	Adjustments to reconcile net loss to net cash used in operating activities:					Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	Stock-based compensation	2,859		2,651		Stock-based compensation	2,231		2,859
Non-cash operating lease expense						Non-cash operating lease expense	921		796
Depreciation and amortization						Depreciation and amortization	79		114
Amortization of costs to obtain a contract with a customer	Amortization of costs to obtain a contract with a customer	1,772		—		Amortization of costs to obtain a contract with a customer	53		1,772
Amortization of operating lease right-of-use assets		796		669
Depreciation and amortization		114		152
Non-cash interest expense	Non-cash interest expense	1		10		Non-cash interest expense	—		1
Amortization of debt issuance costs		—		2

Changes in assets and liabilities:	Changes in assets and liabilities:					Changes in assets and liabilities:
Accounts receivable	Accounts receivable	314		7,303		Accounts receivable	2,978		314
Inventory						Inventory	(2,467)		—
Prepaid expenses, other current assets, and other assets	Prepaid expenses, other current assets, and other assets	(1,662)		713		Prepaid expenses, other current assets, and other assets	2,776		(1,662)
Accounts payable and accrued liabilities	Accounts payable and accrued liabilities	(1,037)		(811)		Accounts payable and accrued liabilities	6,204		(1,037)
Accrued compensation and benefits	Accrued compensation and benefits	(670)		6		Accrued compensation and benefits	(402)		(670)
Deferred revenue		7,314		5,274
Operating lease liabilities		(850)		(630)
Contract liabilities						Contract liabilities	(3,956)		7,314
Lease liabilities						Lease liabilities	(807)		(850)
Net cash used in operating activities	Net cash used in operating activities	(7,471)		(10,325)		Net cash used in operating activities	(9,710)		(7,471)

Investing activities:	Investing activities:					Investing activities:
Purchases of property and equipment	Purchases of property and equipment	(109)		(41)		Purchases of property and equipment	(327)		(109)
Net cash used in investing activities	Net cash used in investing activities	(109)		(41)		Net cash used in investing activities	(327)		(109)

Financing activities:	Financing activities:					Financing activities:

Proceeds from underwritten public offering, net of issuance costs						Proceeds from underwritten public offering, net of issuance costs	17,256		—
Proceeds from public offering of common stock, net of issuance costs	Proceeds from public offering of common stock, net of issuance costs	1,698		11,049		Proceeds from public offering of common stock, net of issuance costs	8,706		1,698
Proceeds from exercise of stock options	Proceeds from exercise of stock options	—		6		Proceeds from exercise of stock options	14		—
Issuance costs for underwritten public offering	Issuance costs for underwritten public offering	(720)		—		Issuance costs for underwritten public offering	—		(720)
Principal repayments of Term Loan	Principal repayments of Term Loan	(2,593)		(3,333)		Principal repayments of Term Loan	—		(2,593)
Net cash (used in) provided by financing activities		(1,615)		7,722
Net decrease in cash, cash equivalents, and restricted cash		(9,195)		(2,644)
Cash, cash equivalents, and restricted cash at beginning of period		62,273		42,949
Cash, cash equivalents, and restricted cash at end of period		$	53,078	$	40,305
Net cash provided by (used in) financing activities						Net cash provided by (used in) financing activities	25,976		(1,615)
Net increase (decrease) in cash and cash equivalents						Net increase (decrease) in cash and cash equivalents	15,939		(9,195)
Cash and cash equivalents at beginning of period						Cash and cash equivalents at beginning of period	32,731		62,273
Cash and cash equivalents at end of period						Cash and cash equivalents at end of period	$	48,670	$	53,078

Supplemental disclosure of cash flows:	Supplemental disclosure of cash flows:					Supplemental disclosure of cash flows:
Interest paid	Interest paid	$	40	$	190	Interest paid	$	—	$	40
Income taxes paid						Income taxes paid	$	651	$	—
Non-cash investing activities:	Non-cash investing activities:					Non-cash investing activities:

Purchases of property and equipment, included in accounts payable and accrued liabilities						Purchases of property and equipment, included in accounts payable and accrued liabilities	$	178	$	—
Right-of-use asset obtained in exchange for lease liability	Right-of-use asset obtained in exchange for lease liability	$	—	$	2,341	Right-of-use asset obtained in exchange for lease liability	$	3,847	$	—
Non-cash financing activities:	Non-cash financing activities:					Non-cash financing activities:
Purchase of shares pursuant to Employee Stock Purchase Plan	Purchase of shares pursuant to Employee Stock Purchase Plan	$	69	$	252	Purchase of shares pursuant to Employee Stock Purchase Plan	$	63	$	69
Proceeds from public offering of common stock, net of issuance costs, included in prepaid expenses and other current assets		$	10	$	—
Proceeds from public offering of common stock, net of issuance costs, included in prepaid expenses, other current assets, and other assets						Proceeds from public offering of common stock, net of issuance costs, included in prepaid expenses, other current assets, and other assets	$	—	$	10

Deferred financing costs incurred but not yet paid		$	—	$	64

See accompanying notes.

CIDARA THERAPEUTICS, INC.

Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(unaudited)


		Three and Nine Months Ended September 30, 2022																		Three and Nine Months Ended September 30, 2023
		Series X Convertible Preferred Stock			Common Stock			Additional Paid-In Capital				Accumulated Deficit						Total Stockholders' Equity (Deficit)						Series X Convertible Preferred Stock					Common Stock				Additional Paid-In Capital			Accumulated Deficit		Total Stockholders’ Equity (Deficit)
(In thousands, except share data)	(In thousands, except share data)	Shares	Amount		Shares	Amount										Total Stockholders' Equity (Deficit)	Shares						Amount		Shares			Amount		Additional Paid-In Capital		Accumulated Deficit			Total Stockholders’ Equity (Deficit)
Balance, December 31, 2021		1,818,472	$	—	67,863,674	$	7			$	398,733			$	(377,167)							$	21,573

Balance, December 31, 2022																					Balance, December 31, 2022			1,818,472		$	—		72,470,440		$	7	$	404,055		$	(406,966)	$	(2,904)
Underwritten public offering, net of issuance costs																					Underwritten public offering, net of issuance costs			286,000		—			11,086,000		1		17,255			—		17,256
Public offering of common stock, net of issuance costs																					Public offering of common stock, net of issuance costs			—		—			6,158,799		1		8,621			—		8,622
Issuance of common stock for exercise of options																					Issuance of common stock for exercise of options			—		—			16,250		—		14			—		14
Issuance of common stock for restricted share units vested																					Issuance of common stock for restricted share units vested			—		—			293,073		—		—			—		—
Stock-based compensation																					Stock-based compensation			—		—			—		—		640			—		640
Net income																					Net income			—		—			—		—		—			3,209		3,209
Balance, March 31, 2023																					Balance, March 31, 2023			2,104,472		—			90,024,562		9		430,585			(403,757)		26,837

Public offering of common stock, net of issuance costs	Public offering of common stock, net of issuance costs	—	—		644,265	—		500				—						500			Public offering of common stock, net of issuance costs			—		—			60,942		—		76			—		76

Issuance of common stock for restricted share units vested	Issuance of common stock for restricted share units vested	—	—		541,308	—		—				—						—			Issuance of common stock for restricted share units vested			—		—			4,875		—		—			—		—
Issuance of common stock under Employee Stock Purchase Plan																					Issuance of common stock under Employee Stock Purchase Plan			—		—			161,367		—		63			—		63
Stock-based compensation	Stock-based compensation	—	—		—	—		1,165				—						1,165			Stock-based compensation			—		—			—		—		795			—		795
Net loss	Net loss	—	—		—	—		—				(18,281)						(18,281)			Net loss			—		—			—		—		—			(12,357)		(12,357)
Balance, March 31, 2022		1,818,472	—		69,049,247	7		400,398				(395,448)						4,957

Balance, June 30, 2023																					Balance, June 30, 2023			2,104,472		—			90,251,746		9		431,519			(416,114)		15,414

Issuance of common stock for restricted share units vested	Issuance of common stock for restricted share units vested	—	—		5,042	—		—				—						—			Issuance of common stock for restricted share units vested			—		—			164,198		—		—			—		—
Issuance of common stock under Employee Stock Purchase Plan		—	—		184,219	—		69				—						69
Stock-based compensation	Stock-based compensation	—	—		—	—		852				—						852			Stock-based compensation			—		—			—		—		796			—		796
Issuance costs for underwritten public offering		—	—		—	—		(720)				—						(720)
Net loss	Net loss	—	—		—	—		—				(13,119)						(13,119)			Net loss			—		—			—		—		—			(8,172)		(8,172)
Balance, June 30, 2022		1,818,472	—		69,238,508	7		400,599				(408,567)						(7,961)

Public offering of common stock, net of issuance costs		—	—		1,664,170	—		1,208				—						1,208

Issuance of common stock for restricted share units vested		—	—		278,519	—		—				—						—
Stock-based compensation		—	—		—	—		842				—						842
Net income		—	—		—	—		—				14,978						14,978
Balance, September 30, 2022		1,818,472	$	—	71,181,197	$	7	$	402,649			$	(393,589)					$	9,067
Balance, September 30, 2023																					Balance, September 30, 2023			2,104,472		$	—		90,415,944		$	9	$	432,315		$	(424,286)	$	8,038


		Three and Nine Months Ended September 30, 2021																		Three and Nine Months Ended September 30, 2022
		Series X Convertible Preferred Stock			Common Stock			Additional Paid-In Capital				Accumulated Deficit						Total Stockholders' Equity (Deficit)						Series X Convertible Preferred Stock					Common Stock				Additional Paid-In Capital			Accumulated Deficit		Total Stockholders’ Equity (Deficit)
(In thousands, except share data)	(In thousands, except share data)	Shares	Amount		Shares	Amount										Total Stockholders' Equity (Deficit)	Shares						Amount		Shares			Amount		Additional Paid-In Capital		Accumulated Deficit			Total Stockholders’ Equity (Deficit)
Balance, December 31, 2020		1,044,278	$	—	44,876,408	$	4			$	345,411			$	(334,700)							$	10,715

Balance, December 31, 2021																					Balance, December 31, 2021			1,818,472		$	—		67,863,674		$	7	$	398,733		$	(377,167)	$	21,573
Public offering of common stock, net of issuance costs	Public offering of common stock, net of issuance costs	—	—		3,327,706	1		8,588				—						8,589			Public offering of common stock, net of issuance costs			—		—			644,265		—		500			—		500
Issuance of common stock for exercise of options		—	—		486	—		1				—						1
Issuance of common stock for restricted share units vested		—	—		84,070	—		—				—						—
Stock-based compensation		—	—		—	—		879				—						879
Net loss		—	—		—	—		—				(18,292)						(18,292)
Balance, March 31, 2021		1,044,278	—		48,288,670	5		354,879				(352,992)						1,892
Public offering of common stock, net of issuance costs		—	—		1,050,928	—		2,058				—						2,058
Issuance of common stock for exercise of options		—	—		2,444	—		5				—						5
Issuance of common stock for restricted share units vested		—	—		18,530	—		—				—						—
Issuance of common stock under Employee Stock Purchase Plan		—	—		145,696	—		252				—						252
Stock-based compensation		—	—		—	—		871				—						871
Net income		—	—		—	—		—				10,711						10,711
Balance, June 30, 2021		1,044,278	—		49,506,268	5		358,065				(342,281)						15,789
Public offering of common stock, net of issuance costs		—	—		113,400	—		235				—						235

Issuance of common stock for restricted share units vested	Issuance of common stock for restricted share units vested	—	—		1,875	—		—				—						—			Issuance of common stock for restricted share units vested			—		—			541,308		—		—			—		—
Stock-based compensation	Stock-based compensation	—	—		—	—		901				—						901			Stock-based compensation			—		—			—		—		1,165			—		1,165
Net loss	Net loss	—	—		—	—		—				(18,083)						(18,083)			Net loss			—		—			—		—		—			(18,281)		(18,281)
Balance, September 30, 2021		1,044,278	$	—	49,621,543	$	5	$	359,201			$	(360,364)					$	(1,158)
Balance, March 31, 2022																					Balance, March 31, 2022			1,818,472		—			69,049,247		7		400,398			(395,448)		4,957

Issuance of common stock for restricted share units vested																					Issuance of common stock for restricted share units vested			—		—			5,042		—		—			—		—
Issuance of common stock under Employee Stock Purchase Plan																					Issuance of common stock under Employee Stock Purchase Plan			—		—			184,219		—		69			—		69
Stock-based compensation																					Stock-based compensation			—		—			—		—		852			—		852
Issuance costs for underwritten public offering																					Issuance costs for underwritten public offering			—		—			—		—		(720)			—		(720)
Net loss																					Net loss			—		—			—		—		—			(13,119)		(13,119)
Balance, June 30, 2022																					Balance, June 30, 2022			1,818,472		—			69,238,508		7		400,599			(408,567)		(7,961)
Public offering of common stock, net of issuance costs																					Public offering of common stock, net of issuance costs			—		—			1,664,170		—		1,208			—		1,208

Issuance of common stock for restricted share units vested																					Issuance of common stock for restricted share units vested			—		—			278,519		—		—			—		—
Stock-based compensation																					Stock-based compensation			—		—			—		—		842			—		842
Net income																					Net income			—		—			—		—		—			14,978		14,978
Balance, September 30, 2022																					Balance, September 30, 2022			1,818,472		$	—		71,181,197		$	7	$	402,649		$	(393,589)	$	9,067

See accompanying notes.

CIDARA THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

1. THE COMPANY AND BASIS OF PRESENTATION

Description of Business

Cidara Therapeutics, Inc., or the Company, was originally incorporated in Delaware in December 2012 as K2 Therapeutics, Inc., and its name was changed to Cidara Therapeutics, Inc. in July 2014. The Company is a biotechnology company focused on ~~the discovery, development and commercialization of long-acting therapeutics~~developing targeted therapies designed to ~~transform~~save lives and improve the standard of care for patients facing serious diseases. The ~~Company~~Company’s first commercially approved product in the United States, or U.S., is ~~focused on infectious diseases~~REZZAYOTM (rezafungin for injection) which is indicated for the treatment of candidemia and ~~oncology.~~invasive candidiasis in adults with limited or no alternative treatment options. Melinta Therapeutics, LLC, or Melinta, is commercializing REZZAYO in the U.S. The Company’s lead product candidate is rezafungin acetate, an intravenous formulation of a novel echinocandin antifungal. Rezafungin is being developed as a once-weekly, high-exposure therapy for the first-line treatment and prevention of serious, invasive fungal infections. In addition, the Company is using itsproprietary Cloudbreak® platform ~~to develop a potential new class~~enables development of ~~drugs called~~novel drug-Fc conjugates, or DFCs, ~~for~~that inhibit specific disease targets while simultaneously engaging the ~~prevention and treatment of serious diseases. This technology couples potent inhibitors to a human antibody fragment to create long-acting DFCs designed to inhibit multiple disease targets.~~immune system. The ~~Company's~~Company’s most advanced DFC program is CD388, a highly potent ~~long-acting~~ antiviral designed to deliver universal prevention and treatment of seasonal and pandemic influenza, which is in Phase 1 and Phase 2a clinical trials. Additional programs are targeting ~~the SARS-CoV-2 strains causing COVID-19~~multiple oncology and ~~multiple solid tumor oncology~~autoimmune indications.

The Company formed wholly-owned subsidiaries, Cidara Therapeutics UK Limited, in England, and Cidara Therapeutics (Ireland) Limited, in Ireland, in March 2016 and October 2018, respectively, for the purpose of developing its product candidates in Europe.

Basis of Presentation

The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. The Company has experienced net losses and negative cash flows from operating activities since its inception. At September 30, ~~2022,~~2023, the Company had an accumulated deficit of ~~$393.6~~$424.3 million. The Company expects to continue to incur net losses into the foreseeable future. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure.

At September 30, ~~2022,~~2023, the Company had cash and cash equivalents of ~~$53.1~~$48.7 million. Based on the Company’s current business plan, management believes that existing cash and cash equivalents will not be sufficient to fund the Company’s obligations for twelve months from the issuance of these financial statements. The Company’s ability to execute its operating plan depends on its ability to obtain additional funding through equity offerings, debt financings or potential licensing and collaboration arrangements. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business. However, the Company’s current working capital, anticipated operating expenses and net losses and the uncertainties surrounding its ability to raise additional capital as needed, as discussed below, raise substantial doubt about its ability to continue as a going concern for a period of one year following the date that these condensed consolidated financial statements are issued. The condensed consolidated financial statements do not include any adjustments for the recovery and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

The Company plans to continue to fund its losses from operations through cash and cash equivalents on hand, as well as through future equity offerings, debt financings, other third party funding, and potential licensing or collaboration arrangements. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to the Company. Even if the Company raises additional capital, it may also be required to modify, delay or abandon some of its plans which could have a material adverse effect on the Company’s business, operating results and financial condition and the Company’s ability to achieve its intended business objectives. Any of these actions could materially harm the Company’s business, results of operations and future prospects.

In addition to the foregoing, the Company is monitoring closely the impact of the COVID-19 pandemic on its business and has taken steps designed to protect the health and safety of its employees while continuing its operations. Given the level of uncertainty regarding the duration and impact of the COVID-19 pandemic on capital markets and the United States, or U.S., economy, the Company is currently unable to assess the impact of the COVID-19 pandemic on its future access to capital. The Company is continuing to monitor the spread of COVID-19 and its potential impact on the Company's operations. The full extent to which the COVID-19 pandemic will impact the Company's business, results of operations,

financial condition, clinical trials, and preclinical research will depend on future developments that are highly uncertain, including actions taken to contain or treat COVID-19 and their effectiveness, as well as the economic impact on national and international markets.

Unaudited Interim Financial Data

The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with U.S. generally accepted accounting principles, or GAAP, as found in the Accounting Standards Codification, or ASC, of the Financial Accounting Standards Board, or FASB. Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim condensed consolidated financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position and results of operations for the interim periods ended September 30, ~~2022~~2023 and ~~2021.~~2022.

Basis of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. The Company evaluates its estimates and assumptions on an ongoing basis. The most significant estimates in the Company’s condensed consolidated financial statements relate to ~~estimating the fair value of the Company’s stock options,~~ estimated collaboration ~~expenses and incurred~~ expenses related to the ~~Company's~~Company’s collaboration and license agreements, certain accruals, including those related to nonclinical and clinical activities, ~~and~~ the stand-alone selling price of performance obligations associated with the ~~Company's~~Company’s collaboration and license ~~agreements.~~agreements, work-in-process inventory and inventory overhead. Although the estimates are based on the Company’s knowledge of current events, comparable companies, and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.

Segment Information

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash and Cash Equivalents ~~and Restricted Cash~~

The Company considers all short-term investments purchased with a maturity of three months or less when acquired to be cash equivalents.

Restricted cash represented cash that the Company was required to maintain on hand in order to maintain compliance with an operating covenant in the Third Amendment to the Company's Loan Agreement with Pacific Western Bank.

~~See Note 4 for additional information.~~

Accounts Receivable

Accounts receivable ~~are recorded~~is stated at ~~their net~~the original invoice ~~value~~amount and ~~are not interest bearing.~~consists of amounts due from customers related to milestones achieved, certain research and development and clinical supply costs subject to reimbursement under the collaboration and license agreements, royalties earned, and product sales. The Company ~~reserves specific~~records accounts receivables ~~when collectability~~net of any allowances for doubtful accounts for potential credit losses. An allowance for doubtful accounts is ~~no longer probable. These reserves are re-evaluated~~determined based on ~~a regular basis~~the financial condition and ~~are adjusted, as needed. Once a receivable~~creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is ~~deemed~~expected to be ~~uncollectable, such balance is recorded~~collected. The payment history of the Company’s customers will be considered in future assessments of collectability as ~~an allowance for~~these patterns are established over a longer period of time. The Company did not record any credit ~~losses. No such allowance existed at~~losses as of September 30, ~~2022~~2023 or December 31, ~~2021.~~2022.

Inventory

The Company began capitalizing inventory for REZZAYO, which received approval by the U.S. Food and Drug Administration, or FDA, in March 2023. REZZAYO (rezafungin for injection) is approved for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred.

Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to materials, third-party contract manufacturing, freight-in and overhead. Inventory is stated at the lower of cost or net realizable value with cost based on the first-in-first-out method. The Company performs an assessment of recoverability of capitalized inventory during each reporting period based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life, and writes down any excess, obsolete or unsaleable inventory to its estimated realizable value in the period which the required reserve is first identified. Such write downs, should they occur, are charged to cost of product revenue in the condensed consolidated statements of operations and comprehensive income (loss). As of September 30, 2023, the Company did not identify any excess, obsolete or unsaleable inventory.

Property and Equipment

The Company records property and equipment at cost, which consists of ~~lab~~laboratory equipment, computer equipment and software, office equipment, furniture and fixtures and leasehold improvements. Property and equipment is depreciated using the straight-line method over the estimated useful lives (generally three to seven years). Leasehold improvements are amortized over the lesser of their useful life or the remaining lease term, including any renewal periods that are deemed to be reasonably assured. Repair and maintenance costs are expensed as incurred.

Income Taxes

The Company follows the FASB ASC 740, Income Taxes, or ASC 740, in reporting deferred income taxes. ASC 740 requires a company to recognize deferred tax assets and liabilities for expected future income tax consequences of events that have been recognized in the Company’s condensed consolidated financial statements. Under this method, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances are provided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions pursuant to ASC 740, which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.

Revenue Recognition

The Company recognizes revenue is accordance with ASC Topic 606, Revenue from Contracts with Customers, or Topic 606, which applies to all contracts with customers, except for elements of certain contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

In a contract with multiple performance obligations, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

Collaboration Revenue

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in a contract, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from the allocated transaction price. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue or expense recognition as a change in estimate.

At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being reached. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or a

collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or a collaboration partner’s control, such as operational developmental milestones and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which will affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative collaboration revenues and earnings in the period of adjustment.

For arrangements that include sales-based royalties, including commercial milestone payments based on the level of sales, and a license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied, or partially satisfied. ~~To date, the Company has not recognized any royalty revenue from collaborative arrangements.~~

In September 2019, the Company entered into a Collaboration and License Agreement, or the Mundipharma Collaboration Agreement, with Mundipharma Medical Company, or Mundipharma. The Company concluded that there were three performance obligations under the Mundipharma Collaboration Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. ~~Revenue associated with the license was recognized upon delivery in September 2019.~~

In March 2021, the Company entered into an exclusive worldwide license and collaboration agreement, or the Janssen Collaboration Agreement, with Janssen Pharmaceuticals, Inc., or Janssen, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Company concluded that there were three performance obligations under the Janssen Collaboration Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. ~~Revenue associated with the license was recognized upon delivery in May 2021.~~

In July 2022, the Company entered into a License Agreement with Melinta, or the Melinta License ~~Agreement, with Melinta Therapeutics, LLC, or Melinta.~~Agreement. The Company concluded that there were three performance obligations under the Melinta License Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. ~~Revenue associated with the license was recognized upon delivery in August 2022.~~

The Company concluded that progress towards completion of the research and development and clinical supply performance obligations related to the Mundipharma Collaboration Agreement and the Melinta License Agreement, is best measured in an amount proportional to the collaboration expenses incurred and the total estimated collaboration expenses. The Company periodically reviews and updates the estimated collaboration expenses, when appropriate, which may adjust revenue recognized for the period. While such changes to the Company’s estimates have no impact on the Company’s reported cash flows, the amount of revenue recorded in the period could be materially impacted. Revenue from research and development services for the Janssen Collaboration Agreement is recognized based on actual amounts billed as the underlying services are provided and billed at market rates. The transaction prices to be recognized as revenue under both the Mundipharma Collaboration Agreement and the Janssen Collaboration Agreement consist of upfront payments, estimated reimbursable research and development and clinical supply costs, and milestones achieved to date. The transaction price to be recognized as revenue under the Melinta License Agreement consists of an upfront ~~payment.~~payment and milestones achieved to date.

Potential future payments for variable consideration, such as clinical, regulatory or commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal will not take place. Potential future royalty payments will be recorded as revenue when the associated sales occur.

See Note 78 for additional information.

Product Revenue

In December 2022 and January 2023, the Company entered into separate Commercial Supply Agreements with Mundipharma and Melinta, respectively, for the batch supply of REZZAYO naked vials for commercial use. Under the Commercial Supply Agreements, Mundipharma and Melinta are required to submit purchase orders to the Company for batches of REZZAYO naked vials. The Company concluded that the delivery of each batch of REZZAYO naked vials and the related quality assessment certification represents a distinct performance obligation.

The transaction price to be recognized as revenue for each performance obligation under the Commercial Supply Agreements consists of variable consideration which is determined based on the estimated per vial costs, plus the contractually stated margin rate. The amounts recognized as revenue are adjusted, as needed, each reporting period based on actual costs incurred for each batch. Variable consideration is included in the transaction price only to the extent that it is considered probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price will be fully allocated to the single performance obligation.

The Company concluded that the performance obligation is satisfied and product revenue is recognized when the customer obtains control of the product, which occurs at a point in time, typically upon the later of (i) completion of a positive quality assessment, or (ii) shipment of the Company’s product to the customer.

Shipping and handling activities that are performed after a customer obtains control of the product are treated as activities to fulfill the promise to a customer and any amounts billed to a customer represent revenues for the product provided. Costs related to such shipping and handling billings are classified as cost of product revenue.

Cost of Product Revenue

Cost of product revenue consists primarily of costs related to materials, third-party contract manufacturing, freight-in and overhead. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred.

Research and Development Costs

Research and development expenses consist of wages, benefits and stock-based compensation charges for research and development employees, scientific consultant fees, facilities and overhead expenses, laboratory supplies, manufacturing expenses in preclinical development and certain manufacturing expenses before FDA approval, and nonclinical and clinical trial costs. The Company accrues nonclinical and clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of studies, and other events.

Costs incurred in purchasing technology assets and intellectual property are charged to research and development expense if the technology has not been conclusively proven to be feasible and has no alternative future use.

Preclinical and Clinical Trial Accruals

The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on the facts and circumstances known at that time. Accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations, or CROs, clinical trial investigational sites and other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones. In accruing for these services, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If possible, the Company obtains information regarding unbilled services directly from these service providers. However, the Company may be required to estimate these services based on other available information. If the Company underestimates or overestimates the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in accruals.

Stock-Based Compensation

The Company accounts for stock-based compensation expense related to stock options, restricted stock units, or RSUs, performance-based RSUs, or PRSUs, and Employee Stock Purchase Plan, or ESPP, rights by estimating the fair value on the date of grant. The Company estimates the fair value of stock options granted to employees and non-employees using the Black-Scholes option pricing model. The fair value of RSUs and PRSUs granted to employees is estimated based on the closing price of the ~~Company's~~Company’s common stock on the date of grant.

The assumptions included in the Black-Scholes option pricing model include (a) the risk-free interest rate, (b) the expected volatility of the ~~Company's~~Company’s stock, (c) the expected term of the award, and (d) the expected dividend yield. The Company computed the expected volatility data using the daily close prices for the ~~Company's~~Company’s common stock during the equivalent period of the calculated expected term of the ~~Company's~~Company’s stock-based awards. The Company estimated the expected life of employee stock options using the “simplified” method, whereby the expected life equals the average of the vesting term and the original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are based on the yields of zero-coupon U.S. treasury securities. The expected dividend yield of zero reflects that the Company has not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future.

For awards subject to time-based vesting conditions, including those with a graded vesting schedule, stock-based compensation expense is recognized using the straight-line method. For performance-based awards to employees, (i) the fair value of the award is determined on the grant date, (ii) the Company assesses the probability of the individual performance milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met.

The Company recognizes forfeitures related to stock-based compensation as they occur and any compensation cost previously recognized for awards for which the requisite service has not been completed is reversed in the period that the award is forfeited.

Net Earnings (Loss) Per Share

The Company follows the guidance in FASB ASC 260, Earnings Per Share, or ASC 260, which establishes standards regarding the computation of earnings per share, or EPS, by companies that have issued securities other than common stock that contractually entitle the holder to participate in dividends and earnings of a company. The guidance requires earnings to be hypothetically allocated between the common, preferred, and other participating stockholders based on their respective rights to receive non-forfeitable dividends, whether or not declared. Participating securities include Series X Convertible Preferred Stock (see Note 5)6). Basic net ~~earnings per share~~EPS is then calculated by dividing the net income ~~allocable~~attributable to common stockholders (after the reduction for any preferred stock and assuming current income for the period had been distributed) by the weighted-average number of common shares outstanding for the period. The Company calculates diluted net ~~earnings per share~~EPS by using the more dilutive of the (1) ~~if-converted~~treasury stock method, reverse treasury stock method or ~~contingently issuable share~~if-converted method, as applicable, or (2) the two-class ~~method.~~

Basic net loss per share is calculated by dividing the net loss allocable to common shares by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss allocable to common shares by the weighted-average number of common shares and dilutive stock equivalents outstanding for the period determined using the if-converted method. Dilutive common stock equivalents are comprised of warrants, Series X Convertible Preferred Stock, RSUs, PRSUs and options outstanding under the Company’s stock option ~~plans.~~plans and ESPP, on an as converted basis.

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive stock equivalents outstanding for the period determined using the treasury stock method or if-converted method. Under the two-class method, the net loss attributable to common stockholders is not allocated to the Series X Convertible Preferred Stock as the preferred stockholders do not have a contractual obligation to share in the Company’s losses. In loss periods, basic and diluted net loss per share are identical because the otherwise dilutive potential common shares become anti-dilutive and are therefore excluded.

1213

The following table sets forth the computation of basic and diluted net earnings (loss) per common share (in thousands, except share and per share data):


		Three Months Ended September 30,				Nine Months Ended September 30,					Three Months Ended September 30,				Nine Months Ended September 30,
		2022		2021		2022		2021			2023		2022		2023		2022
Numerator:	Numerator:									Numerator:
Net income (loss)	Net income (loss)	$	14,978	$	(18,083)	$	(16,422)	$	(25,664)	Net income (loss)	$	(8,172)	$	14,978	$	(17,320)	$	(16,422)
Allocation of earnings to participating securities	Allocation of earnings to participating securities	(3,081)		—		—		—		Allocation of earnings to participating securities	—		(3,081)		—		—

Numerator for basic net earnings (loss) per share - net income (loss) attributable to common stockholders		$	11,897	$	(18,083)	$	(16,422)	$	(25,664)
Numerator for basic net earnings (loss) per common share - net income (loss) attributable to common stockholders										Numerator for basic net earnings (loss) per common share - net income (loss) attributable to common stockholders	$	(8,172)	$	11,897	$	(17,320)	$	(16,422)

Effect of participating securities:	Effect of participating securities:									Effect of participating securities:
Add back allocation of earnings to participating securities	Add back allocation of earnings to participating securities	3,081		—		—		—		Add back allocation of earnings to participating securities	—		3,081		—		—
Numerator for diluted net earnings (loss) per share - net income (loss) attributable to common stockholders after assumed conversions		$	14,978	$	(18,083)	$	(16,422)	$	(25,664)
Numerator for diluted net earnings (loss) per common share - net income (loss) attributable to common stockholders										Numerator for diluted net earnings (loss) per common share - net income (loss) attributable to common stockholders	$	(8,172)	$	14,978	$	(17,320)	$	(16,422)

Denominator:	Denominator:									Denominator:
Denominator for basic net earnings (loss) per share - common shares outstanding		70,217,985		49,533,956		69,170,865		48,402,095
Denominator for basic net earnings (loss) per common share - weighted average common shares outstanding										Denominator for basic net earnings (loss) per common share - weighted average common shares outstanding	90,287,441		70,217,985		86,390,446		69,170,865
Effect of dilutive securities:	Effect of dilutive securities:									Effect of dilutive securities:
Series X Convertible Preferred Stock, as converted	Series X Convertible Preferred Stock, as converted	18,184,720		—		—		—		Series X Convertible Preferred Stock, as converted	—		18,184,720		—		—
Common stock options, RSUs, PRSUs, and ESPP	Common stock options, RSUs, PRSUs, and ESPP	189,863		—		—		—		Common stock options, RSUs, PRSUs, and ESPP	—		189,863		—		—
Denominator for diluted net earnings (loss) per share - adjusted weighted average shares outstanding		88,592,568		49,533,956		69,170,865		48,402,095
Denominator for diluted net earnings (loss) per common share - adjusted weighted average common shares outstanding										Denominator for diluted net earnings (loss) per common share - adjusted weighted average common shares outstanding	90,287,441		88,592,568		86,390,446		69,170,865

Basic net earnings (loss) per common share	Basic net earnings (loss) per common share	$	0.17	$	(0.37)	$	(0.24)	$	(0.53)	Basic net earnings (loss) per common share	$	(0.09)	$	0.17	$	(0.20)	$	(0.24)
Diluted net earnings (loss) per common share	Diluted net earnings (loss) per common share	$	0.17	$	(0.37)	$	(0.24)	$	(0.53)	Diluted net earnings (loss) per common share	$	(0.09)	$	0.17	$	(0.20)	$	(0.24)

The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of basic and diluted net ~~earnings (loss)~~loss per share because doing so would be anti-dilutive (in common stock equivalent shares):


		Three Months Ended September 30,		Nine Months Ended September 30,			Three Months Ended September 30,		Nine Months Ended September 30,
		2022	2021	2022	2021		2023	2022	2023	2022
Common stock warrants	Common stock warrants	12,517,328	12,517,328	12,517,328	12,517,328	Common stock warrants	17,331	12,517,328	17,331	12,517,328
Series X Convertible Preferred Stock	Series X Convertible Preferred Stock	—	10,442,780	18,184,720	10,442,780	Series X Convertible Preferred Stock	21,044,720	—	21,044,720	18,184,720
Common stock options, RSUs and PRSUs issued and outstanding	Common stock options, RSUs and PRSUs issued and outstanding	10,041,333	10,356,267	10,086,839	10,356,267	Common stock options, RSUs and PRSUs issued and outstanding	12,924,675	10,041,333	12,924,675	10,086,839
Total	Total	22,558,661	33,316,375	40,788,887	33,316,375	Total	33,986,726	22,558,661	33,986,726	40,788,887

Fair Value of Financial Instruments

The Company follows ASC 820-10 issued by the FASB with respect to fair value reporting for financial assets and liabilities. The guidance defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels.

The Company’s financial instruments consist of cash and cash equivalents, ~~restricted cash,~~ accounts receivable, accounts payable, accrued liabilities, accrued compensation and benefits, and lease ~~liability, and a term loan. Fair value estimates of these instruments are made at each~~

reporting period end based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment and therefore cannot be determined with precision.liability. The carrying amount of ~~cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and accrued liabilities~~these financial instruments are generally considered to be representative of their respective fair values because of ~~the~~their short-term ~~nature of those instruments.~~nature.

Recently Issued ~~Accounting Standards~~

and Recently Adopted Accounting ~~Standards~~Pronouncements

~~In August 2020,~~From time to time, new accounting pronouncements are issued by the FASB ~~issued ASU 2020-06, "Accounting for Convertible Instruments and Contracts in an Entity's Own Equity," simplifies~~or other standard setting bodies that are adopted by the accounting for certain convertible instruments by removing the separation models for convertible debt with a cash conversion feature or convertible instruments with a beneficial conversion feature. As a result, more convertible debt instruments will be reportedCompany as ~~a single liability instrument with no separate accounting for embedded conversion features. Additionally, this ASU amends the diluted EPS calculation for convertible instruments by requiring the use~~ of the ~~if-converted method. The treasury stock method is no longer available. Entities may adopt this ASU using either a full or modified retrospective approach, and it is~~specified effective ~~for interim and annual reporting periods beginning after December 15, 2021. Early adoption is permitted for interim and annual reporting periods beginning after December 15, 2020.~~date. The Company believes, based on its preliminary assessment, that the recently issued, but not yet adopted, ~~ASU 2020-06 effective January 1, 2022. The adoption of this standard did~~accounting pronouncements will not have a material impact on the ~~Company's~~Company’s condensed consolidated financial ~~statements.~~statements or related disclosures, or do not apply to the Company.

3. FAIR VALUE MEASUREMENTS

The Company follows ASC 820-10, Fair Value Measurements and Disclosures, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement determined based on assumptions that market participants would use in pricing an asset or liability.

As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

Level 3: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.

The Company classifies investments in money market ~~funds~~accounts within Level 1 as the prices are available from quoted prices in active markets.

None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented.

The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis (in thousands):


		TOTAL		LEVEL 1		LEVEL 2		LEVEL 3			TOTAL		LEVEL 1		LEVEL 2		LEVEL 3
September 30, 2022
September 30, 2023										September 30, 2023
Assets:	Assets:									Assets:
Cash and money market accounts	Cash and money market accounts	$	53,078	$	53,078	$	—	$	—	Cash and money market accounts	$	48,670	$	48,670	$	—	$	—

Total assets at fair value	Total assets at fair value	$	53,078	$	53,078	$	—	$	—	Total assets at fair value	$	48,670	$	48,670	$	—	$	—

December 31, 2021
December 31, 2022										December 31, 2022
Assets:	Assets:									Assets:
Cash and money market accounts	Cash and money market accounts	$	59,680	$	59,680	$	—	$	—	Cash and money market accounts	$	32,731	$	32,731	$	—	$	—
Restricted cash and money market accounts		2,593		2,593		—		—

Total assets at fair value	Total assets at fair value	$	62,273	$	62,273	$	—	$	—	Total assets at fair value	$	32,731	$	32,731	$	—	$	—

1415

4. INVENTORY

Inventory consisted of the following (in thousands):


	September 30, 2023		December 31, 2022
Raw materials	$	733	$	—
Work-in-process	1,734		—
Finished goods	—		—
Total inventory	$	2,467	$	—

The Company’s capitalized inventory consists of costs incurred subsequent to FDA approval of REZZAYO in March 2023. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. There were no inventory write downs during the nine months ended September 30, 2023.

5. DEBT

Term Loan

On October 3, 2016, the Company entered into a loan and security agreement, or the Loan Agreement, with Pacific Western Bank, as the collateral agent and a lender, or the Lender, pursuant to which the Company has borrowed $10.0 million from the Lender, or the Term A Loan. The Term A Loan bore interest at a variable annual rate equal to the greater of (i) 4.5% or (ii) the ~~Lender's~~Lender’s prime interest rate plus 0.75%, and matured on July 3, 2022. The Term A Loan had an interest-only period through April 3, 2020, which was followed by equal monthly principal payments and was paid in full on July 5, 2022.

5.6. STOCKHOLDERS’ EQUITY

Controlled Equity Sales Agreement

In September 2019, the Company began to sell shares of common stock under a controlled equity sales agreement, or the Sales Agreement, entered into on November 8, 2018 with Cantor Fitzgerald & Co, or Cantor. During the ~~Sales Agreement.~~nine months ended September 30, 2023, the Company sold 6,219,741 shares of common stock, at a weighted average price of $1.44 per share for gross proceeds of approximately $9.0 million, and for net proceeds of approximately $8.7 million after deducting placement agent fees. During the nine months ended September 30, 2022, ~~and 2021,~~ the ~~company~~Company sold 2,308,435 ~~and 4,492,034~~ shares of common stock ~~respectively,~~ for net proceeds of approximately $1.7 million ~~and $10.9 million, respectively,~~ after deducting placement agent fees. As of September 30, ~~2022,~~2023, the ~~aggregate offering price~~ remaining capacity under the Sales Agreement is ~~$46.8~~$37.1 million.

~~2021~~2023 Underwritten Public Offering

On ~~October 13, 2021,~~March 7, 2023, the Company completed concurrent but separate underwritten public offerings ~~of 17,064,511~~with Cantor, the underwriter, to issue and sell 11,086,000 shares of its common stock, including the exercise in full by ~~the underwriters~~Cantor of their option to purchase an additional ~~2,225,805~~1,446,000 shares of common stock, and 286,000 shares of the Company’s Series X Convertible Preferred Stock. Cantor agreed to purchase the shares of common stock at a price ~~to the public~~ of ~~$1.55~~$1.267 per share and ~~774,194~~the shares of ~~its~~ Series X Convertible Preferred Stock at a price ~~to the public~~ of ~~$15.50~~$12.67 per ~~share, for aggregate~~share. The total gross proceeds from the offerings, including the full exercise by Cantor of ~~$38.5 million.~~its option to purchase additional shares of common stock, were approximately $19.5 million, before deducting underwriting discounts and commissions and offering expenses. The Company received total net proceeds of ~~$35.8~~approximately $17.3 million, after deducting underwriting discounts, commissions, and other expenses payable by the Company.

Preferred Stock

Under the amended and restated certificate of incorporation, the Company’s board of directors has the authority, without further action by the stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding. The Company had 10,000,000 shares of preferred stock authorized at September 30, ~~2022.~~2023.

In May 2018, the Company designated 5,000,000 shares of preferred stock as Series X Convertible Preferred Stock with a par value of $0.0001 per share.

On August 12, 2020, at the request of certain holders, 52,241 shares of the Company’s Series X Convertible Preferred Stock were converted to an aggregate of 522,410 shares of the Company’s common stock. As of September 30, ~~2022~~2023 and December 31, ~~2021,~~2022, shares of preferred stock designated as Series X Convertible Preferred Stock totaled 4,947,759.

The specific terms of the Series X Convertible Preferred Stock are as follows:

Conversion: Each share of Series X Convertible Preferred Stock is convertible at the option of the holder into 10 shares of common stock. Holders are not permitted to convert Series X Convertible Preferred Stock into common stock if, after conversion, the holder, its affiliates, and any other person whose beneficial ownership of common stock would be aggregated with the ~~holder's~~holder’s for purposes of Section 13(d) or Section 16 of the Exchange Act, would beneficially own more than 9.99% of the number of shares of common stock outstanding immediately after the conversion.

Dividends: Holders of Series X Convertible Preferred Stock are not entitled to receive any dividends except to the extent that dividends are paid on the ~~Company's~~Company’s common stock. If dividends are paid on shares of common stock, holders of Series X Convertible Preferred Stock are entitled to participate in such dividends on an as-converted basis.

Liquidation: Upon the liquidation, dissolution, or winding up of the ~~company,~~Company, each holder of Series X Convertible Preferred Stock will participate pari passu with any distribution of proceeds to holders of common stock.

Voting: Shares of Series X Convertible Preferred Stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series X Convertible Preferred Stock will be required to amend the terms of the Series X Convertible Preferred Stock, if such action would adversely alter or

change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series X Convertible Preferred Stock, or to increase or decrease (other than by conversion) the number of authorized shares of Series X Convertible Preferred Stock.

The Company evaluated the Series X Convertible Preferred Stock for liability or equity classification under ASC 480, Distinguishing Liabilities from Equity, and determined that equity treatment was appropriate because the Series X Convertible Preferred Stock did not meet the definition of liability instruments defined thereunder as convertible instruments. Additionally, the Series X Convertible Preferred Stock is not redeemable for cash or other assets (i) on a fixed or determinable date, (ii) at the option of the holder, and (iii) upon the occurrence of an event that is not solely within control of the Company. As such, the Series X Convertible Preferred Stock is recorded as permanent equity.

Common Stock

The Company had 200,000,000 shares of common stock authorized as of September 30, ~~2022.~~2023. Holders of outstanding shares of common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the holders of common stock. Subject to the rights of the holders of any class of the Company’s capital stock having any preference or priority over common stock, the holders of common stock are entitled to receive dividends that are declared by the Company’s board of directors out of legally available funds. In the event of a liquidation, dissolution or winding-up, the holders of common stock are entitled to share ratably in the net assets remaining after payment of liabilities, subject to prior rights of preferred stock, if any, then outstanding. The common stock has no preemptive rights, conversion rights, redemption rights or sinking fund provisions, and there are no dividends in arrears or default. All shares of common stock have equal distribution, liquidation and voting rights, and have no preferences or exchange rights.

Common Stock Warrants

As of September 30, ~~2022 and~~2023, warrants to purchase 17,331 shares of the Company’s common stock were outstanding with a weighted average exercise price of $11.54 per share. During the nine months ended September 30, 2023, 12,499,997 common stock warrants expired unexercised.

As of December 31, ~~2021,~~2022, warrants to purchase 12,517,328 shares of the ~~Company's~~Company’s common stock were outstanding with a weighted average exercise price of $6.82 per share.

The warrants had no intrinsic value at September 30, ~~2022~~2023 and December 31, ~~2021.~~2022. The intrinsic value of a common stock warrant is the difference between the market price of the common stock at the measurement date and the exercise price of the warrant.

Common Stock Reserved for Future Issuance

Common stock reserved for future issuance is as follows (in common stock equivalent shares):


		September 30, 2022	December 31, 2021		September 30, 2023	December 31, 2022
Common stock warrants	Common stock warrants	12,517,328	12,517,328	Common stock warrants	17,331	12,517,328
Series X Convertible Preferred Stock	Series X Convertible Preferred Stock	18,184,720	18,184,720	Series X Convertible Preferred Stock	21,044,720	18,184,720
Stock options, RSUs and PRSUs issued and outstanding		10,086,839	9,470,178
Common stock options, RSUs and PRSUs issued and outstanding				Common stock options, RSUs and PRSUs issued and outstanding	12,924,675	9,323,495
Authorized for future stock awards	Authorized for future stock awards	3,710,000	2,436,984	Authorized for future stock awards	3,288,730	4,469,969
Awards available under the ESPP	Awards available under the ESPP	986,345	680,228	Awards available under the ESPP	1,135,937	806,968
Total	Total	45,485,232	43,289,438	Total	38,411,393	45,302,480

6.7. EQUITY INCENTIVE PLANS

2020 Inducement Incentive Plan and 2015 Equity Incentive Plan

In December 2020, the ~~Company's~~Company’s board of directors approved and adopted the 2020 Inducement Incentive Plan, or 2020 IIP. Under the 2020 IIP, the Company may grant stock options, stock appreciation rights, restricted stock, RSUs, and other awards to individuals who were not previously employees or directors of the Company, or who are returning to employment following a bona fide period of non-employment with the Company, as an inducement material to such persons entering into employment with the Company.

In March 2015, the Company’s board of directors and stockholders approved and adopted the 2015 Equity Incentive Plan, or 2015 EIP. Under the 2015 EIP, the Company may grant stock options, stock appreciation rights, restricted stock, RSUs, and other awards to individuals who are employees, officers, directors or consultants of the Company. The number of shares of stock available for issuance under the 2015 EIP is automatically increased each January 1 by 4% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31 or such lesser number as determined by the Company’s board of directors.

Terms of stock award agreements, including vesting requirements, are determined by the board of directors, subject to the provisions of the 2020 IIP and 2015 EIP. Stock options granted by the Company generally vest over a three- or four-year period. Certain stock options are subject to acceleration of vesting in the event of certain change of control transactions. The stock options may be granted for a term of up to 10 years from the date of grant. The exercise price for stock options granted under the 2020 IIP and 2015 EIP must be at a price no less than 100% of the fair value of the shares on the date of grant, provided that for an incentive stock option granted to an employee who at the time of grant owns stock representing more than 10% of the voting power of all classes of stock of the Company, the exercise price shall be no less than 110% of the value on the date of grant.

2015 Employee Stock Purchase Plan

In March 2015, the Company’s board of directors and stockholders approved and adopted the 2015 Employee Stock Purchase Plan, or the ESPP. The number of shares of stock available for issuance under the ESPP will be automatically increased each January 1 by the lesser of (i) 1% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31, (ii) 490,336 shares, or (iii) such lesser number as determined by the Company’s board of directors.

The ESPP allows substantially all employees to purchase the Company’s common stock through a payroll deduction at a price equal to 85% of the lower of the fair market value of the stock as of the beginning or the end of each purchase period. An employee’s payroll deductions under the ESPP are limited to 15% of the employee’s eligible compensation.

During the nine months ended September 30, 2023 and 2022, ~~and 2021, 184,219~~161,367 shares and ~~145,696~~184,219 shares, respectively, were issued pursuant to the ESPP. As of September 30, ~~2022,~~2023, total unrecognized compensation expense related to the ESPP was ~~approximately $0.3 million. This unrecognized compensation cost~~immaterial and is expected to be recognized over approximately ~~0.6~~0.3 years.

Restricted Stock Units

The following table summarizes RSU and PRSU activity during the nine months ended September 30, ~~2022:~~2023:


		Number of RSUs and PRSUs	Weighted Average Grant Date Fair Value			Number of RSUs and PRSUs	Weighted Average Grant Date Fair Value
Outstanding at December 31, 2021		1,174,087	$	2.53
Outstanding at December 31, 2022					Outstanding at December 31, 2022	1,223,871	$	1.47
RSUs and PRSUs granted	RSUs and PRSUs granted	1,471,454	0.83		RSUs and PRSUs granted	1,465,817	1.00
RSUs and PRSUs vested	RSUs and PRSUs vested	(1,032,815)	1.59		RSUs and PRSUs vested	(462,146)	1.51
RSUs and PRSUs canceled	RSUs and PRSUs canceled	(320,532)	2.06		RSUs and PRSUs canceled	(127,201)	1.29
Outstanding at September 30, 2022		1,292,194	$	1.47
Outstanding at September 30, 2023					Outstanding at September 30, 2023	2,100,341	$	1.15

The weighted-average grant date fair value of RSUs and PRSUs granted by the Company during the nine months ended September 30, ~~2021~~2022 was ~~$2.28~~$0.83 per share. The total fair value of RSUs and PRSUs vested during the nine months ended September 30, ~~2022~~2023 and ~~2021~~2022 was approximately ~~$1.6~~$0.7 million and ~~$0.4~~$1.6 million, respectively.

At September 30, ~~2022,~~2023, estimated unrecognized compensation expense related to RSUs and PRSUs ~~grants~~granted was approximately ~~$1.7~~$2.0 million.

Stock Options

The following table summarizes stock option activity during the nine months ended September 30, ~~2022:~~2023:

Number of
Shares
Weighted
Average
Exercise Price
Weighted
Average
Remaining
Contractual Life
in Years
Total Aggregate
Intrinsic Value (in thousands)
Outstanding at December 31, 2021 8,296,091 $ 3.21 6.31 $ —
Options granted 2,014,700 0.80
Options exercised — —
Options canceled (1,516,146) 2.72
Outstanding at September 30, 2022 8,794,645 $ 2.74 6.46 $ 19
Vested and expected to vest at September 30, 2022 8,794,645 $ 2.74 6.45 $ 19
Exercisable at September 30, 2022 5,749,660 $ 3.38 5.32 $ —


	Number of Shares	Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years	Total Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2022	8,099,624	$	2.78	6.65	$	48
Options granted	3,233,558	1.02
Options exercised	(16,250)	0.83
Options canceled	(492,598)	3.60
Outstanding at September 30, 2023	10,824,334	$	2.22	6.99	$	246
Vested and expected to vest at September 30, 2023	10,824,334	$	2.22	6.99	$	246
Exercisable at September 30, 2023	6,874,604	$	2.83	5.77	$	163

The intrinsic value of a stock option is the difference between the market price of the common stock at the measurement date and the exercise price of the option.

The weighted-average grant date fair value of stock options granted by the Company during the nine months ended September 30, 2023 and 2022 was $0.72 and ~~2021 was~~ $0.51 ~~and $1.43~~ per share, respectively.

As of September 30, ~~2022,~~2023, total unrecognized share-based compensation expense related to unvested stock options was approximately ~~$2.8~~$3.0 million. This unrecognized compensation cost is expected to be recognized over a weighted-average period of approximately 2.0 years.

Stock-based compensation expense recognized for ~~restricted shares,~~ RSUs, PRSUs, stock options, and the ESPP has been reported in the condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands):


		Three Months Ended September 30,				Nine Months Ended September 30,					Three Months Ended September 30,				Nine Months Ended September 30,
		2022		2021		2022		2021			2023		2022		2023		2022
Research and development	Research and development	$	443	$	425	$	1,366	$	1,215	Research and development	$	393	$	443	$	1,193	$	1,366
General and administrative	General and administrative	399		476		1,666		1,436		General and administrative	403		399		1,038		1,666
Total	Total	$	842	$	901	$	3,032	$	2,651	Total	$	796	$	842	$	2,231	$	3,032

8. SIGNIFICANT AGREEMENTS AND CONTRACTS

Mundipharma Collaboration Agreement

On September 3, 2019, the Company entered into the Mundipharma Collaboration Agreement with Mundipharma, a related party, for a strategic collaboration to develop and commercialize rezafungin in an intravenous formulation, or the Mundipharma Licensed Product, for the treatment and prevention of invasive fungal infections.

Collaboration. Under the Mundipharma Collaboration Agreement, the Company is responsible for leading the conduct of an agreed global development plan, or the Global Development Plan, that includes the Company’s ongoing Phase 3 pivotal clinical trial of the Mundipharma Licensed Product for the treatment of candidemia and/or invasive candidiasis, or the ReSTORE Trial, and the Company’s ongoing Phase 3 pivotal clinical trial of the Mundipharma Licensed Product for the prophylaxis of invasive fungal infections in adult allogeneic blood and marrow transplant recipients, or the ReSPECT Trial, as well as specified GLP-compliant non‑clinical studies and chemistry, manufacturing and controls, or CMC, development activities for the Mundipharma Licensed Product. Mundipharma is responsible for performing all development activities, other than Global Development Plan activities, that may be necessary to obtain and maintain regulatory approvals for the Mundipharma Licensed Product inoutside of the U.S. and Japan, or the Mundipharma Territory, at Mundipharma’s sole cost.

Licenses. Pursuant to the Mundipharma Collaboration Agreement, the Company granted Mundipharma an exclusive, royalty‑bearing license to develop, register and commercialize the Mundipharma Licensed Product ~~outside of the U.S. and Japan, or~~in the Mundipharma Territory, subject to the Company’s retained right as described below.

The Company also granted Mundipharma an option to obtain exclusive licenses to develop, register and commercialize rezafungin in a formulation for subcutaneous administration, or Subcutaneous Product, and in formulations for other

modes of administration, or Other Products, in the Mundipharma Territory, subject to similar retained rights of the Company to conduct mutually agreed global development activities for such products. In addition, the Company granted Mundipharma a co‑exclusive, worldwide license to manufacture the Mundipharma Licensed Product and rezafungin.

Until the seventh anniversary of the first commercial sale of the Mundipharma Licensed Product in the Mundipharma Territory, each party has granted the other party an exclusive, time-limited right of first negotiation to obtain a license to any anti-fungal product (other than Mundipharma Licensed Product, Subcutaneous Product and Other Products) that such party proposes to out-license in the other party’s territory.

The Company’s Retained Rights.As of September 30, ~~2022,~~2023, the Company retained the exclusive right to develop, register and commercialize the Mundipharma Licensed Product, Subcutaneous Product and Other Products in Japan, or the Company Territory, and Mundipharma has granted the Company certain licenses under Mundipharma-controlled technology and jointly-developed technology to develop, register and commercialize Mundipharma Licensed Product, Subcutaneous Product and Other Products in the Company Territory and to manufacture such products and rezafungin worldwide.

Financial Terms. As of the execution of the Mundipharma Collaboration Agreement, the parties have agreed to share equally (50/50) the costs of Global Development Plan activities, or Global Development Costs, subject to a cap on Mundipharma’s Global Development Cost share of $31.2 million. The total potential transaction value is $568.4 million, including an equity investment, an up-front payment, global development funding, and certain development, regulatory, and commercial milestones. The Company is also eligible ~~for~~to receive double-digit royalties in the teens on tiers of annual net sales.

Termination. Either party may terminate the Mundipharma Collaboration Agreement for uncured material breach by the other party. Mundipharma may terminate the Mundipharma Collaboration Agreement at will, provided that if Mundipharma terminates the Mundipharma Collaboration Agreement in its entirety prior to the last visit of the last patient in both the ReSTORE Trial and the ReSPECT Trial, Mundipharma will continue to be liable for its share of Global Development Costs as described above. The Company may terminate the Mundipharma Collaboration Agreement if Mundipharma or any of its affiliates or sublicensees, directly or indirectly through any third party, commences any interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any of the ~~Company's~~Company’s patent rights licensed to Mundipharma, or upon an insolvency event of Mundipharma.

Revenue Recognition

As of September 30, ~~2022,~~2023, the Company determined the transaction price is equal to the up-front fee of $30.0 million, plus the research and development funding of ~~$32.2~~$31.2 million, plus milestones achieved of $13.9 million. The common stock issued pursuant to the Mundipharma Stock Purchase Agreement was determined to be issued at fair market value after applying a lack of marketability discount as Mundipharma received restricted shares. Therefore, no additional premium or discount was allocated to the transaction price of the Mundipharma Collaboration Agreement for the share issuance.

The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company utilized discounted cash flows and developed assumptions that required judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. A description of the distinct performance obligations identified under the Mundipharma Collaboration Agreement, as well as the amount of revenue allocated to each distinct performance obligation, is as follows:

Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The license and associated know-how was transferred to Mundipharma during September 2019, therefore the Company recognized the ~~full~~ revenue related to this performance obligation in the amount of $17.9 million in September 2019 as collaboration revenue in its condensed consolidated statements of operations and comprehensive income (loss).

Research and Development Services. The Company and Mundipharma share equally in the costs of ongoing rezafungin clinical development in the Mundipharma Territory up to the specified cap, which represents a distinct performance obligation. The Company records these cost-sharing payments due from Mundipharma as collaboration revenue. The Company concluded that progress towards completion of the performance obligation related to the research and development services is best measured in an amount proportional to the research and development expenses incurred and the total estimated research and development expenses.

Clinical Supply Services. The ~~Company's~~Company’s initial obligation to supply rezafungin for ongoing clinical development in the Mundipharma Territory represents a distinct performance obligation. The Company concluded that progress towards completion of the performance obligations related to the clinical supply services is best measured in an amount proportional to the clinical supply services expenses incurred and the total estimated clinical supply services.

Milestone Payments. The Company determined that as of September 30, 2022, all remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the

Company's control or are otherwise constrained under the variable consideration guidance. Therefore, these payments have been fully constrained and are therefore not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint. In November 2020, the Company achieved a $11.1 million milestone under the Mundipharma Collaboration Agreement, which is recorded as long-term ~~deferred revenue~~contract liabilities as of September 30, ~~2022~~2023 because the rights to consideration is not expected to be satisfied within one year. The Company received payment for this milestone in January 2021. Mundipharma is entitled to credit the full amount of this milestone payment toward future royalties payable to the Company, subject to a limit on the amount by which royalty payments to the Company may be reduced in any quarter. If Mundipharma has not fully credited the amount of such milestone payment toward royalties payable to the Company before the earlier of (i) December 31, 2024 and (ii) termination of the Mundipharma Collaboration Agreement by Mundipharma, the Company will be obligated to refund the uncredited portion of such milestone payment to Mundipharma on the earlier of such dates. As of September 30, 2023, the Company estimated the uncredited portion to be approximately $10.1 million in December 2024. In December 2021 and August 2022, the Company achieved milestones of $2.8 million and $11.1 million, respectively, under the Mundipharma Collaboration Agreement that the Company deems to be tied to all the performance obligations identified in the original agreement. Revenue associated with these milestones has been allocated proportionately to the original transaction price which was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In conjunction with the performance obligations already delivered, revenue is recognized based on the progress of these performance obligations, the unrecognized portion is recorded as ~~deferred revenue~~contract liabilities at the reporting period end and will be recognized as revenue over the remaining progress of these performance obligations. The Company received payment for these milestones in January 2022 and September 2022, respectively. The Company determined that as of September 30, 2023, all remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company’s control or are otherwise constrained under the variable consideration guidance. Therefore, these milestone payments have been fully constrained and are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint.

Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize royalty revenue when the related sales occur. No royalty revenue was recognized during the three and nine months ended September 30, ~~2022~~2023 and ~~2021.~~2022.

Janssen Collaboration Agreement

On March 31, 2021, the Company and Janssen entered into the Janssen Collaboration Agreement to develop and commercialize one or more DFCs ~~(previously called Antiviral Drug Conjugates, or AVCs)~~ based on the ~~Company's~~Company’s Cloudbreak platform, for the prevention and treatment of influenza, including CD388 and CD377, or the Products. The effectiveness of the Janssen Collaboration Agreement, including the effectiveness of the terms and conditions described below, was subject to the expiration or earlier termination of all applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, or HSR. HSR clearance was obtained on May 12, 2021 and the Janssen Collaboration Agreement became effective on the same date.

Collaboration. The Company and Janssen will collaborate in the research, preclinical development and early clinical development of CD388 or another mutually-agreed influenza DFC development candidate, or, in each case, the Development Candidate, under a mutually-agreed research and development plan, or the Research Plan, with the objective of advancing such Development Candidate through the completion of mutually-agreed Phase 1 clinical trials and the first Phase 2 ~~Challenge~~clinical trial, or Phase 2 Study. Unless otherwise agreed by the parties, the Company will be responsible for performing, or having performed, all investigational new drug application, or IND, -enabling studies and clinical trials under the Research Plan, and the Company will be the IND holder for the Research Plan clinical trials. Both parties will be responsible for conducting certain specified ~~chemistry, manufacturing and controls~~CMC development activities under the Research Plan. Janssen will be solely responsible, and reimburse the Company, for internal full-time equivalent and out-of-pocket costs incurred by the Company in performing Research Plan activities in accordance with a mutually-agreed budget.

~~Within 90 days after delivery by the Company~~As part of a recent prioritization of its R&D business, in July 2023 Janssen disclosed its intention to Janssen of results of the Phase 2 Challenge Study and all then-available data from other clinical trials of the Development Candidate conducted under the Research Plan, or the Election Period, Janssen will be obligated to notify the Company of Janssen’s election to proceed with further clinicaldiscontinue internal development of ~~Products, such notice, an Election to Proceed Notice. If~~multiple product candidates in its infectious disease pipeline, including CD388. However, in September 2023 Janssen ~~fails to deliver an~~delivered its Election to Proceed Notice ~~prior~~for CD388 whereby Janssen will assume the future development, manufacturing and commercialization activities of CD388 but intends to ~~expiration of the Election Period, the Company will have the right to terminate~~transfer its rights and obligations under the Janssen Collaboration Agreement ~~upon written notice~~ to ~~Janssen. If~~another transferee. The Company continues to work in collaboration with Janssen ~~provides an~~to complete the Phase 1 and Phase 2a clinical trials and will be reimbursed for all ongoing development activities by Janssen as per the Janssen Collaboration Agreement.

Following Janssen’s Election to Proceed Notice, ~~prior~~Janssen, or any third-party transferee, is obligated at its sole expense to ~~expiration of the Election Period, then the parties will~~diligently continue ~~any then-ongoing Research Plan activities to completion, and Janssen will otherwise be solely responsible for the~~ development ~~manufacture~~ and commercialization ~~of Products, at Janssen’s sole expense.~~either itself or through the transferee to whom it sublicenses or assigns the rights. If Janssen sublicenses or assigns the rights to a third party, then all terms under the current Janssen Collaboration Agreement will survive without modification.

Licenses. Upon the effectiveness of the Janssen Collaboration Agreement, the Company granted Janssen an exclusive, worldwide, royalty-bearing license to develop, register and commercialize Products, subject to the Company’s retained right to conduct Research Plan activities as described above. In addition, the Company granted Janssen an exclusive right of first negotiation until December 31, 2021, to negotiate and enter into a separate definitive agreement pursuant to which the parties would collaborate in the research and development of DFCs for the treatment or prevention of respiratory syncytial virus. This right of first negotiation expired on December 31, 2021.

Non-Compete Covenant. The Company will covenant that, except for the performance of Research Plan activities, from the effectiveness of the Janssen Collaboration Agreement until the fifth anniversary of the completion of all Research Plan activities and the Company’s delivery to Janssen of all Research Plan deliverables, the Company and its affiliates will not directly or indirectly (including through any third-party contractor or through or in collaboration with any third-party licensee) develop, file any IND or application for marketing approval for, or commercialize any DFC that binds influenza or influenza viral proteins at therapeutic levels, except that the Company has the right to conduct limited internal research of such DFCs for the purposes of generating data to support patent filings and improving and further developing the Company’s DFC technology more broadly. The Company’s non-compete covenant described above will not apply to any DFC that demonstrates high specificity for a virus other than the influenza virus and does not possess significant activity against the influenza virus.

Financial Terms. Upon the effectiveness of the Janssen Collaboration Agreement, Janssen paid the Company an upfront payment of $27.0 million. As of the execution of the Janssen Collaboration Agreement, the Company iswas eligible for reimbursement by Janssen of up to $58.2 million in research and development costs incurred in conducting Research Plan activities. The Company will also be eligible to receive up to ~~an additional~~ $695.0 million in development, regulatory and commercial milestone payments, as well as royalties on tiers of annual net sales at rates from the mid-single digits to the high-single digits.

Termination. In addition to the Company’s right to terminate the Janssen Collaboration Agreement for Janssen’s failure to deliver the Election to Proceed Notice prior to expiration of the Election Period, the Janssen Collaboration Agreement includes standard termination provisions upon material breach, insolvency or safety concerns. In addition, Janssen may terminate the Janssen Collaboration Agreement for convenience as follows:

•prior to the completion of all Research Plan activities and the Company’s delivery to Janssen of all Research Plan deliverables, upon 90 days’ written notice to the Company, provided that if any clinical trial under the Research Plan is ongoing at the time of such termination, such clinical trial will be completed in accordance with the terms of the Janssen Collaboration Agreement;

•after completion of the Phase 2 ~~Challenge~~ Study and before expiration of the Election Period, immediately upon written notice to the Company; or

•after delivery of the Election to Proceed Notice, upon 90 days’ written notice to the Company, which termination may be of the Janssen Collaboration Agreement in its entirety or on a country-by-country or Product-by-Product basis.

Revenue Recognition

As of September 30, ~~2022,~~2023, the Company determined the transaction price is equal to the up-front fee of $27.0 million, plus the research and development funding of ~~$61.2~~$50.2 million, plus milestones achieved of ~~$3.0~~$10.0 million. The transaction price includes the total estimated costs related to research and development and clinical supply services, which can increase or decrease as costs to continue the research and development efforts become known. No revenue was reversed due to the change in transaction price as revenue is recognized based on actual amounts billed. The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company utilized discounted cash flows and developed assumptions that required judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success, costs to continue the research and development efforts and costs for manufacturing clinical supplies. A description of the distinct performance obligations identified under the Janssen Collaboration Agreement, as well as the amount of revenue allocated to each distinct performance obligation, is as follows:

Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The license and associated know-how was transferred to Janssen in May 2021, therefore the Company recognized the revenue related to this performance obligation in the amount of $27.0 million in May 2021 as collaboration revenue in its condensed consolidated statements of operations and comprehensive income (loss).

Research and Development Services. The research and development services to be performed represents a distinct performance obligation. The Company recognizes revenue based on actual amounts incurred as the underlying services are provided and billed at fair value.

Clinical Supply Services. The ~~Company's~~Company’s initial obligation to supply drug supply for ongoing development represents a distinct performance obligation. The Company recognizes revenue based on actual amounts incurred as the underlying services are provided and billed at fair value.

Milestone Payments. The Company determined that as of the latest financial statement date all remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company's control or are otherwise constrained under the variable consideration guidance. Therefore, these payments have been fully constrained and are not included in the transaction price. At the end of each

~~subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint.~~ In March 2022 and September 2023, the Company achieved amilestones of $3.0 million ~~milestone~~and $7.0 million, respectively, under the Janssen Collaboration Agreement that the Company deems to be tied to all the performance obligations identified in the original agreement. Revenue associated with ~~the milestone~~these milestones has been allocated proportionately to the original transaction price which was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In conjunction with the performance obligations already delivered, revenue is recognized based on the progress of these performance obligations, the unrecognized portion is recorded as ~~deferred revenue~~contract liabilities at the reporting period end and will be recognized as revenue over the remaining progress of these performance obligations. The Company received payment for ~~this milestone~~these milestones in May ~~2022.~~2022 and September 2023, respectively. The Company determined that as of September 30, 2023, all remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company’s control or are otherwise constrained under the variable consideration guidance. Therefore, these milestone payments have been fully constrained and are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint.

Melinta License Agreement

On July 26, 2022, the Company entered into the Melinta License Agreement with Melinta under which the Company granted Melinta an exclusive license to develop and commercialize products that contain or incorporate rezafungin, or the Melinta Licensed Product, in the U.S., or the Melinta Territory.

Licenses. Pursuant to the Melinta License Agreement, the Company granted Melinta an exclusive, royalty‑bearing license (including the right to sublicense through multiple tiers), to develop, register and commercialize the Melinta Licensed Product for all uses in humans and non-human animals in the Melinta Territory, subject to the Company’s retained right, as described below.

Non-Compete Covenant. Until the fifth anniversary of the first commercial sale of the first Melinta Licensed Product in the Melinta Territory, neither the Company nor Melinta, nor any of their respective majority-owned subsidiaries may, directly or indirectly, itself or in collaboration with any ~~Third Party,~~third party, develop, manufacture for development or commercialization, or commercialize any product in the echinocandin class of drugs in the Melinta Territory without the other party’s prior written consent, subject to certain provisions in connection with a change of control of a party.

Commercialization. Melinta will be solely responsible for the commercialization of rezafungin in the Melinta Territory, at its sole expense.

The Company’s Retained Rights. The Company retains the non-exclusive right to practice the intellectual property rights licensed to Melinta in the Melinta Territory solely for the purpose of performing its obligations under the Melinta License Agreement and Mundipharma Collaboration Agreement. The Company also retains the right to grant licenses under the intellectual property rights licensed to Melinta to third parties to which the Company has granted licenses or rights to market, promote and sell Melinta Licensed Product outside the Melinta Territory, to make and have made Melinta Licensed Product anywhere in the world solely to develop, register, use, sell, have sold, offer for sale, commercialize and import Melinta Licensed Product outside the Melinta Territory, subject to the terms of the Melinta License Agreement.

Continued Development and Regulatory Activities. The Company will be responsible, at its sole expense, for conducting an agreed upon development plan, or the Melinta Development Plan, that includes, among other activities, (a) completion of the ongoing ReSPECT Phase 3 pivotal clinical trial for the prophylaxis of invasive fungal infections in adult allogeneic blood and marrow transplant recipients, or the Prophylaxis Indication, (b) preparation and submission to the ~~U.S. Food and Drug Administration, or~~ FDA of a supplemental ~~New Drug Application,~~new drug application, or ~~NDA,~~sNDA, for the Melinta Licensed Product in the Prophylaxis Indication, (c) site close-out activity worldwide (outside of China) for the Company’s ReSTORE Phase 3 pivotal clinical trial for the treatment of candidemia and invasive candidiasis, or the Treatment Indication, (d) certain nonclinical studies and other nonclinical activities, (e) certain ~~chemistry, manufacturing and controls~~CMC activities for the Melinta Licensed Product, and (f) all other development activities that are required by the FDA to obtain marketing approval of the Melinta Licensed Product in the Treatment Indication and the Prophylaxis Indication in the Melinta Territory.

The Company will remain the holder of ~~all FDA submissions, including~~ the rezafungin IND and new drug application, or NDA. ~~The FDA submissions~~Both regulatory applications will transfer to Melinta on a transfer date determined based on the status of the ReSPECT trial and the associated ~~supplemental NDA~~sNDA for the Prophylaxis Indication, after which Melinta will be responsible for performing all activities that may be necessary to maintain NDA approvals for the Melinta Licensed Product in the Treatment Indication and the Prophylaxis Indication in the Melinta Territory, at Melinta’s sole expense, subject to Melinta’s right to deduct from royalties payable to the Company the internal expenses (not to exceed a specified dollar amount per calendar year) and certain out-of-pocket expenses incurred by Melinta.

Supply and Transfer of CMC activities. Until Melinta assumes responsibility for the manufacture and supply of the Melinta Licensed Product for development and commercialization in the Melinta Territory, which it may do by direct purchase from the Company’s contract manufacturing organizations for the Melinta Licensed Product or by having a manufacturing

technology transfer to Melinta or its designee performed at Melinta’s sole expense, which, in either case, will be no later than December 31, 2026, the Company will be responsible for the manufacture and supply of the Melinta Licensed Product for development and commercialization by Melinta in the Melinta Territory, and during such period, shall supply Melinta Licensed Product to Melinta pursuant to the terms of a supply agreement ~~to be~~ negotiated by the parties.

Financial Terms. Upon execution of the Melinta License Agreement, the total potential transaction value is $460.0 million, including a $30.0 million upfront payment and up to $430.0 million in regulatory and commercial ~~milestones.~~milestone payments. In addition, the Company is eligible ~~for~~to receive tiered royalties on U.S. sales in the low double digits to mid-teens.

Termination. Either party may terminate the Melinta License Agreement for uncured material breach by the other party. After July 26, 2023, Melinta may terminate the Melinta License Agreement at will. The Company may terminate the Melinta License Agreement if Melinta or any of its affiliates or sublicensees, directly or indirectly through any third party, commences any interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any of the patent rights licensed to Melinta by the Company.

Revenue Recognition

As of September 30, ~~2022,~~2023, the Company determined the transaction price is equal to the up-front fee of $30.0 million, plus a milestone achieved of $20.0 million. The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company utilized discounted cash flows and developed assumptions that required judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success, costs to continue the research and development efforts and costs for manufacturing clinical supplies. A description of the distinct performance obligations identified under the Melinta License Agreement, as well as the amount of revenue allocated to each distinct performance obligation, is as follows:

Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The license and associated know-how was transferred to Melinta in August 2022, therefore the Company recognized the ~~full~~ revenue related to this performance obligation in the amount of $25.9 million in August 2022 as collaboration revenue in its condensed consolidated statements of operations and comprehensive income (loss).

Research and Development Services. The Company is required to provide research and development services, at its sole expense, as described under the Melinta Development Plan, which represents a distinct performance obligation. The Company concluded that progress towards completion of the performance obligation related to the research and development services is best measured in an amount proportional to the research and development expenses incurred and the total estimated research and development expenses.

Clinical Supply Services. The ~~Company's~~Company’s obligation to supply rezafungin for ongoing clinical development in the Melinta Territory represents a distinct performance obligation. The Company concluded that progress towards completion of the performance obligations related to the clinical supply services is best measured in an amount proportional to the clinical supply services expenses incurred and the total estimated clinical supply services. Revenue related to the clinical supply services performance obligation recognized during the three and nine months ended September 30, ~~2022~~2023 was immaterial.

Milestone Payments. In March 2023, the Company achieved a $20.0 million milestone under the Melinta License Agreement that the Company deems to be tied to all the performance obligations identified in the original agreement. Revenue associated with the milestone has been allocated proportionately to the original transaction price which was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In conjunction with the performance obligations already delivered, revenue is recognized based on the progress of these performance obligations, the unrecognized portion is recorded as contract liabilities at the reporting period end and will be recognized as revenue over the remaining progress of these performance obligations. The Company received payment for this milestone in April 2023. The Company determined that as of September 30, ~~2022,~~2023, all remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the ~~Company's~~Company’s control or are otherwise constrained under the variable consideration guidance. Therefore, these milestone payments have been fully constrained and are ~~therefore~~ not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint. ~~No revenue related to milestones was recognized during the three and nine months ended September 30, 2022.~~

Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize royalty revenue when the related sales occur. The Company recognized $0.1 million in royalty revenue during the three and nine months ended September 30, 2023 following initiation of the commercial launch of REZZAYO by Melinta in the U.S. on July 31, 2023. No royalty revenue was recognized during the three and nine months ended September 30, 2022.

Costs to Obtain a Contract with a Customer

The Company incurred costs to a third party to obtain the Melinta License Agreement and capitalized $2.0 million upon execution of the Melinta License Agreement, and capitalized an additional $0.5 million upon achievement of a milestone, in accordance with ASC 340. The Company incurred these costs in connection with all the performance obligations identified in the Melinta License Agreement and allocated the capitalized contract costs to performance obligations on a relative basis (i.e., in proportion to the transaction price allocated to each

performance obligation) to determine the period of amortization. Amortization during the three and nine months ended September 30, ~~2022~~2023 was ~~$1.8~~immaterial and $0.5 million, respectively, and is included within general and administrative expenses in the ~~Company's~~Company’s condensed consolidated statements of operations and comprehensive income (loss). As of September 30, ~~2022,~~2023, the remaining balance of the asset recognized from costs to obtain the Melinta License Agreement was $0.2 million.

Contract Liabilities

The following table presents a summary of the activity in the ~~Company's~~Company’s contract liabilities ~~(recorded as deferred revenue on the balance sheet)~~ pertaining to the Mundipharma Collaboration Agreement, Janssen Collaboration Agreement, and Melinta License Agreement during the nine months ended September 30, ~~2022~~2023 (in thousands):


Opening balance, December 31, ~~2021~~2022	$	~~32,333~~35,139
Payments received in advance	~~11,319~~2,209
Payments receivable	70
Revenue from performance obligations satisfied during reporting period	~~(4,005)~~(6,235)
Closing balance, September 30, ~~2022~~2023	$	~~39,647~~31,183

Current portion of ~~deferred revenue~~contract liabilities	$	~~15,249~~14,679
Long-term portion of ~~deferred revenue~~contract liabilities	~~24,398~~16,504
Total ~~deferred revenue,~~contract liabilities, September 30, ~~2022~~2023	$	~~39,647~~31,183

As of September 30, ~~2022,~~2023, the aggregate transaction price allocated to performance obligations that are unsatisfied is ~~$18.0~~$11.2 million, ~~$39.5~~$7.0 million, and ~~$3.8~~$4.2 million under the Mundipharma Collaboration Agreement, Janssen Collaboration Agreement, and Melinta License Agreement, respectively. These amounts are expected to be recognized over 2.3 years, ~~1.3~~0.8 years, and 2.3 years which represent the remaining research periods under the Mundipharma Collaboration Agreement, Janssen Collaboration Agreement, and Melinta License Agreement, respectively.

As of September 30, 2023, the Company recorded $0.4 million, $2.4 million and $0.1 million in accounts receivable associated with the Mundipharma Collaboration Agreement, Janssen Collaboration Agreement and Melinta License Agreement, respectively. As of December 31, 2022, the Company recorded ~~$0.5~~$0.2 million and ~~$4.5~~$5.6 million in accounts receivable associated with the Mundipharma Collaboration Agreement and Janssen Collaboration Agreement, respectively.

The following table presents our ~~contract revenues~~collaboration revenue disaggregated by collaborator and timing of revenue recognition ~~and excludes royalty revenue~~ (in thousands):


		Three Months Ended September 30, 2022						Nine Months Ended September 30, 2022							Three Months Ended September 30, 2023						Nine Months Ended September 30, 2023
		Mundipharma		Janssen		Melinta		Mundipharma		Janssen		Melinta			Mundipharma		Janssen		Melinta		Mundipharma		Janssen		Melinta
Revenue from Collaboration and License Agreements:	Revenue from Collaboration and License Agreements:													Revenue from Collaboration and License Agreements:
Point in Time:	Point in Time:													Point in Time:
License of Intellectual Property		$	3,252	$	—	$	25,885	$	3,252	$	816	$	25,885

License of Intellectual Property - upon milestone achieved														License of Intellectual Property - upon milestone achieved	$	—	$	2,347	$	—	$	—	$	2,347	$	17,257
Clinical Drug Supply	Clinical Drug Supply	459		—		—		459		—		—		Clinical Drug Supply	—		—		—		26		—		—
Royalty Revenue														Royalty Revenue	—		—		70		—		—		70
Over Time:	Over Time:													Over Time:
Research and Development Services	Research and Development Services	3,945		6,250		328		7,965		11,235		328		Research and Development Services	1,550		5,592		408		4,870		16,324		1,859
Clinical Supply Services	Clinical Supply Services	363		262		—		792		3,337		—		Clinical Supply Services	5		1,278		—		245		1,856		—
Total Revenue from Collaboration and License Agreements	Total Revenue from Collaboration and License Agreements	$	8,019	$	6,512	$	26,213	$	12,468	$	15,388	$	26,213	Total Revenue from Collaboration and License Agreements	$	1,555	$	9,217	$	478	$	5,141	$	20,527	$	19,186

Three Months Ended
September 30, 2021 Nine Months Ended
September 30, 2021
Mundipharma Janssen Melinta Mundipharma Janssen Melinta
Revenue from Collaboration and License Agreements:
Point in Time:
License of Intellectual Property $ — $ — $ — $ — $ 27,000 $ —
Clinical Drug Supply — — — — — —
Over Time:
Research and Development Services 3,033 2,072 — 7,795 3,747 —
Clinical Supply Services 237 1,734 — 598 3,207 —
Total Revenue from Collaboration and License Agreements $ 3,270 $ 3,806 $ — $ 8,393 $ 33,954 $ —


	Three Months Ended September 30, 2022						Nine Months Ended September 30, 2022
	Mundipharma		Janssen		Melinta		Mundipharma		Janssen		Melinta
Revenue from Collaboration and License Agreements:
Point in Time:
License of Intellectual Property - upon transfer of license	$	—	$	—	$	25,885	$	—	$	—	$	25,885
License of Intellectual Property - upon milestone achieved	3,252		—		—		3,252		816		—
Clinical Drug Supply	459		—		—		459		—		—

Over Time:
Research and Development Services	3,945		6,250		328		7,965		11,235		328
Clinical Supply Services	363		262		—		792		3,337		—
Total Revenue from Collaboration and License Agreements	$	8,019	$	6,512	$	26,213	$	12,468	$	15,388	$	26,213

8.9. COMMITMENTS AND CONTINGENCIES

Lease Obligations

On ~~July 14, 2021,~~April 20, 2023, the Company entered into a ~~sixth~~seventh amendment to its lease with Nancy Ridge Technology Center, L.P. which extended the term of the lease by an additional 2436 months and increases the base rent to ~~$103,733~~$133,371 per month effective January 1, ~~2022,~~2024, subject to 3%4% increases every January. The lease expires on December 31, ~~2023~~2026 with options for two individual two-year extensions, as described in the original lease agreement, which have not been exercised, and remain in effect and available to the Company. As of September 30, ~~2022,~~2023, the Company was not reasonably certain that it would exercise the extension options, and therefore did not include these options in the determination of the total lease term for accounting purposes. The incremental borrowing rate used in measuring the ~~Company's~~Company’s lease liability was ~~10.8%~~12.0%.

The following table presents information about the amount, timing and uncertainty of cash flows arising from the ~~Company's~~Company’s operating lease as of September 30, ~~2022~~2023 (in thousands):


2022		$	340
2023	2023	1,400		2023	$	321
2024				2024	1,600
2025				2025	1,665
2026				2026	1,731
Total undiscounted operating lease payments	Total undiscounted operating lease payments	$	1,740	Total undiscounted operating lease payments	$	5,317
Less: Imputed interest	Less: Imputed interest	(119)		Less: Imputed interest	(960)
Present value of lease payments	Present value of lease payments	$	1,621	Present value of lease payments	$	4,357

The balance sheet classification of the ~~Company's~~Company’s operating lease is as follows (in thousands):


Balance Sheet Classification:
Operating lease right-of-use asset	$	~~1,491~~4,131

Current portion of lease liability	$	~~1,277~~1,051
~~Lease~~Long-term lease liability	~~344~~3,306
Total operating lease liability	$	~~1,621~~4,357

As of September 30, ~~2022,~~2023, the weighted average remaining lease term was ~~1.3~~3.3 years.

Cash paid for amounts included in the ~~present value~~measurement of operating lease liabilities was $1.0 ~~million and $0.7~~ million for the nine months ended September 30, ~~2022~~2023 and ~~2021, respectively.~~2022.

Operating lease costs were ~~$1.0~~$1.2 million and ~~$0.9~~$1.0 million for the nine months ended September 30, ~~2022~~2023 and ~~2021~~2022, respectively. These costs are primarily related to the ~~Company's long-term~~Company’s operating lease, but also include immaterial amounts for variable leases and short-term leases with terms greater than 30 days.

Contractual Obligations

The Company enters into contracts in the normal course of business with vendors for research and development activities, manufacturing, and professional services. These contracts generally provide for termination either on notice or after a notice period.

10. INCOME TAXES

The Company estimates an annual effective income tax rate based on projected results for the year and applies this rate to net loss before taxes to calculate income tax expense. When applicable, the income tax provision also includes adjustments for discrete tax items. Any refinements made due to subsequent information that affects the estimated annual effective income tax rate are reflected as adjustments in the current period. For the three and nine months ended September 30, 2023, the Company recognized an income tax expense of $0.2 million and $0.4 million, respectively, resulting in effective tax rates of -2.90% and -2.24%, respectively. The effective tax rate for the three and nine months ended September 30, 2023 varies from the U.S. federal statutory rate of 21% primarily due to the change in the valuation allowance against net deferred tax assets and tax benefits relating to research and development tax credits.

Current year tax expense is primarily the result of capitalized Internal Revenue Code, or IRC, Section 174 research and development expenditures, effective January 1, 2022, creating taxable income which can be partially offset with net operating losses and credits that are limited in use by IRC Sections 382 and 383.

Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing deferred tax assets. Based on the weight of all evidence, including a history of operating losses, management has determined that it is more likely than not that the net deferred tax assets will not be realized.

In general, under IRC Section 382, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses and tax credit carryforwards to offset future taxable income. An ownership change occurs when a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has completed an IRC Section 382/383 analysis regarding the limitation of net operating losses and research and development credit carryforwards through 2022 and has adjusted the tax attributes for the annual limitation.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, or our Quarterly Report, and our Annual Report on Form 10-K, or our Annual Report, for the year ended December 31, ~~2021,~~2022, filed with the Securities and Exchange Commission, or the SEC, on March ~~7, 2022.~~23, 2023.

Forward-Looking Statements

The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning our strategy, clinical and nonclinical data, future operations, future financial position, future revenues, projected costs, prospects and plans and objectives of management and the impact of the COVID-19 pandemic on the foregoing. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II, Item 1A, “Risk Factors” in this Quarterly Report and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements.

~~Overview~~OVERVIEW

We are a biotechnology company focused on ~~the discovery, development and commercialization of long-acting therapeutics~~developing targeted therapies designed to ~~transform~~save lives and improve the standard of care for patients facing serious diseases. ~~We are focused on infectious diseases and oncology.~~

Our ~~lead~~first commercially approved product ~~candidate~~in the United States, or U.S., is REZZAYOTM (rezafungin ~~acetate, an intravenous formulation of a novel echinocandin antifungal. Rezafungin~~for injection) which is ~~being developed as a once-weekly, high-exposure therapy~~indicated for the ~~first-line~~ treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. On July 31, 2023, Melinta Therapeutics, LLC, or Melinta, our commercial partner in the U.S., initiated the commercial launch of REZZAYO in the U.S. On October 2, 2023, Melinta announced receipt from the Centers for Medicare & Medicaid Services, or CMS, of both a product-specific J-Code and a new technology add-on payment, or NTAP, for REZZAYO. Outside the U.S. and Japan, our development and commercial partner is Mundipharma Medical Company, or Mundipharma. On October 12, 2023, Cidara and Mundipharma received a positive opinion from the European Medicines Agency’s, or EMA, Committee for Medicinal Products for Human Use, or CHMP, for rezafungin for the treatment of invasive candidiasis in adults. The European Commission, or EC, will review the CHMP recommendation and is expected to make a final decision on approval by the end of 2023.

Although we have shifted our research focus to our proprietary Cloudbreak® platform, we continue to execute on the ongoing ReSPECT Phase 3 pivotal clinical trial for the prevention of ~~serious,~~ invasive fungal ~~infections.~~infections in adult allogeneic blood and marrow transplant recipients. A significant portion of our future royalties and milestones to be received under both Melinta and Mundipharma licensing agreements are tied to the successful completion of the ReSPECT Phase 3 trial.

~~In addition, we are using our~~Our proprietary Cloudbreak platform ~~to develop a potential new class~~enables development of ~~drugs called~~novel drug-Fc conjugates, or DFCs, ~~for~~that inhibit specific disease targets while simultaneously engaging the ~~prevention and treatment of serious diseases. This technology couples potent inhibitors to a human antibody fragment to create long-acting DFCs designed to inhibit multiple disease targets.~~immune system. Our most advanced DFC program is CD388, a highly potent ~~long-acting~~ antiviral designed to deliver universal prevention and treatment of seasonal and pandemic influenza, which is in Phase 1 and Phase 2a clinical trials. Additional programs are targeting ~~the SARS-CoV-2 strains causing COVID-19~~multiple oncology and ~~multiple solid tumor oncology~~autoimmune indications.

Our business is subject to various trends, events or uncertainties that are reasonably likely to cause our reported financial information not to be necessarily indicative of future operating results or of future financial condition. As discussed below, the COVID-19 pandemic has delayed our conduct of clinical trials and other key activities and there is uncertainty regarding the emergence of potential new COVID-19 strains. We may also be impacted by broader macroeconomic conditions, high inflation, and supply chain disruptions. The stock market, and in particular the market for pharmaceutical and biotechnology company stocks, has recently experienced significant decreases in value. This volatility and valuation decline have affected the market prices of securities issued by many companies, often for reasons unrelated to their operating performance. These and other uncertainties are discussed in greater detail below.

~~Recent Developments~~

~~Initiation of Phase 2a trial~~

~~In September 2022, we initiated a Phase 2a trial (NCT05523089) to evaluate the pre-exposure prophylactic activity of CD388 against influenza virus.~~

The Phase 2a trial, which dosed its first healthy volunteer in September 2022, is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept study to assess the prophylactic antiviral activity, safety, tolerability and pharmacokinetics of CD388 against influenza via a human viral challenge (influenza) model. Multiple dose levels of CD388 will be evaluated in volunteers who will receive a single administration of CD388 or placebo prior to influenza viral challenge. The trial is expected to enroll up to 168 healthy adults. Results are expected in the first half of 2023.

~~NDA accepted by the FDA~~

The U.S. Food and Drug Administration, or FDA, accepted for filing and granted Priority Review to our New Drug Application, or NDA, for rezafungin for the treatment of candidemia and invasive candidiasis, in September 2022. The FDA has assigned a Prescription Drug User Fee Act target action date of March 22, 2023, enabled by rezafungin's designation as a Qualified Infectious Disease Product, and is planning to hold an advisory committee meeting to discuss the application.

~~Compliance with Nasdaq listing requirements~~

On October 6, 2022, we attended a hearing before the Nasdaq Hearings Panel, or the Panel, and presented our plan to regain compliance with The Nasdaq Capital Market’s, or Nasdaq, $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a), and requested that the Panel allow us additional time within which to regain compliance. On October 18, 2022, the Panel granted our request for continued listing on Nasdaq, pursuant to an extension, through February 27, 2023. The extension is subject to certain specified conditions and our submission of certain interim updates to the Panel. To evidence compliance with the minimum bid price requirement, we must report a closing bid price of at least $1.00 per share for a minimum of ten consecutive trading days on or before February 27, 2023.

Cloudbreak Platform

We believe our Cloudbreak platform has the potential to offer a fundamentally new approach to ~~prevent~~treat and ~~treat~~prevent serious diseases such as solid tumor cancers and viral infections, by developing product candidates designed to provide potent disease targeting activity and immune system engagement in a single long-acting molecule. Because serious disease often results when a pathogen or cancer cell evades or overcomes the host immune system, our Cloudbreak DFC candidates are designed to counter diseases in two ways: prevention of disease proliferation or immune evasion by directly targeting and, where applicable, by focusing the immune system on a pathogen or infected cell. We believe this is a potentially transformative approach, distinct from current therapies, including antibody drug conjugates, or ADCs, monoclonal or multispecific antibodies and vaccines.

In addition, DFCs are designed to have several advantages, including:

•Multivalent binding which has the potential to increase potency;

•Ability to engage different targets ~~on the same target cell to decrease resistance or, in the case of a cancerous cell,~~ to serve as a “drug cocktail” in a single molecule, which may improve response to ~~treatment;~~

•~~Potential to target multiple viral pathogens or oncological targets with a single DFC;~~treatment and prevention; and

•Potential ~~for universal coverage against all viral variants and all people~~advantages over vaccines irrespective of the immune ~~status.~~status of patients.

DFCs are fundamentally different from ADCs: DFCs are biologically stable drug-Fc conjugates designed to engage extracellular targets, while ADCs are designed to enter target cells to deliver and release cytotoxic small molecule drugs. In contrast to ADCs and monoclonal antibodies, ~~our~~ DFCs are smaller, ~~have~~providing the potential for better tissue penetration and are designed to target multiple sites. Unlike small molecules, we believe DFC optimization can be focused primarily on potency.

Our lead Cloudbreak ~~candidates are DFCs~~candidate for the prevention ~~and~~of influenza is CD388, a DFC in a Phase 2a clinical trial. Our lead oncology DFC is CBO421, a development candidate targeting CD73 for the treatment of ~~influenza,~~solid tumors, which is in investigational new drug application, or ~~influenza DFCs.~~ IND, -enabling studies.

Cloudbreak Influenza Program

In September 2020, we nominated CD388, our influenza DFC, as a development candidate. We submitted an IND for CD388 in December 2021 and initiated a Phase 1 trial (NCT05285137) in March 2022. The Phase 1 trial is a randomized, double-blind, dose-escalation study to determine the safety, tolerability and pharmacokinetics of intramuscular and subcutaneous administration of CD388 in healthy subjects. ~~Dosing~~Enrollment of all six planned cohorts has been ~~initiated as planned.~~completed and follow-up is ongoing. In addition, a separate Phase 1 Japanese bridging study (NCT05619536) has been ~~initiated.~~initiated and enrollment has been completed.

~~All~~In September 2022, we initiated a Phase 2a trial (NCT05523089) to evaluate the pre-exposure prophylactic activity of CD388 against influenza virus. The Phase 2a trial, which dosed its first healthy volunteer in September 2022, is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept study to assess the prophylactic antiviral activity, safety, tolerability and pharmacokinetics of CD388 against influenza via a human viral challenge (influenza) model. Multiple dose levels of CD388 will be evaluated in volunteers who will receive a single administration of CD388 or placebo prior to influenza viral challenge. Enrollment has now been completed.

In December 2022, we received the first U.S. patent for CD388. The patent includes claims directed to the composition of matter of CD388. The patent is projected to expire in 2039 plus any available patent term extension.

In June 2023, the U.S. Food and Drug Administration, or FDA, granted Fast Track designation to CD388 for the prevention of influenza A and B infection in adults who are at high risk of influenza complications due to underlying immunodeficiency and may not mount an adequate response to influenza vaccine or are at high risk of severe influenza despite influenza vaccination, including those for whom vaccines are contraindicated. Fast Track designation aims to facilitate the development and expedite the review of drugs to treat serious conditions with unmet medical needs. The purpose is to get important new drugs to patients earlier. Companies that are granted this designation are given the opportunity for more frequent interactions with the FDA, and, if relevant criteria are met, eligibility for Priority Review.

CD388 Phase 2a Results

In our recent R&D Day, on September 21, 2023, we announced efficacy and safety data from our Phase 1 and Phase 2a trials ~~are being conducted under~~evaluating the ~~Janssen Collaboration Agreement (as defined below).~~pre-exposure prophylactic activity of CD388 against an H3N2 influenza A virus strain.

CD388 was well-tolerated up to 900 milligrams, or mg:


Number of participants that received one dose of CD388 in Phase 1 and Phase 2a trials
	First in Human Study (Phase 1)	Japanese Bridging Study (Phase 1)	Human Challenge Study (Phase 2a)	Total
50 mg	18	7	2	27
150 mg	18	7	28	53
450 mg	18	7	—	25
900 mg	9	—	—	9
All Doses1	63	21	30	114
1 Safety Summary: •No treatment-emergent serious adverse events, or SAEs, and no discontinuation of study drug or withdrawals due to safety findings. •No consistent adverse event, or AE, patterns. •No hypersensitivity reactions. •Most treatment-emergent adverse events, or TEAEs, were Grade 1 (90%), few Grade 2, all resolved. •Incidence of TEAE not dose-dependent. •Few injection site events (pain, intramuscular, or IM, route mainly), Grade 1, all resolved spontaneously. •No clinically relevant electrocardiogram, or ECG, vital signs or physical exam abnormalities.

CD388 pharmacokinetics, or PK, profile is that of a long-acting compound, potentially enabling seasonal pre-exposure prophylaxis, or PrEP:

CD388 demonstrates prophylactic reduction of viral replication in the upper respiratory tract, or URT, and the incidence of PCR-confirmed influenza infection:

The ~~Cloudbreak platform has also enabled us to expand~~Phase 2a prophylactic efficacy results are based on 56 subjects enrolled in the ~~development of DFCs to target other life-threatening viral diseases including Coronavirus strains causing COVID-19.~~

~~In addition, we have expanded the Cloudbreak platform beyond infectious diseases, to discover and develop highly potent DFCs that can target multiple immune checkpoint pathways~~trial, with 28 subjects receiving a single ~~DFC for oncologic diseases.~~dose of CD388 (150 mg) and 28 subjects receiving a placebo.

~~On July 7, 2022, we presented preliminary~~


	Placebo (n=28)	CD388 150 mg (n=28)	P-value2
Quantitative reverse transcriptase polymerase chain reaction, or qRT-PCR, confirmed influenza infection (“attack rate” see Placebo data)	14 (50%)	6 (21%)	0.0248
qRT-PCR confirmed symptomatic influenza infection	9 (32%)	4 (14%)	0.1023
qRT-PCR confirmed moderately to severe symptomatic influenza infection	7 (25%)	3 (11%)	0.1477
2 Statistical significance was pre-determined using a Wilcoxon rank-sum test with a one-sided type-1 error rate of 0.025.

As shown above, despite the small sample size in this analysis, a decrease in viral replication in the upper respiratory tract and influenza infection was observed in participants receiving a single dose of CD388 when compared to placebo. No treatment emergent adverse events leading to study discontinuation or serious adverse events were reported in the analysis. All participants included in the analysis received either CD388 or placebo and were then challenged with influenza five days later.

Viral culture data ~~on our Oncology and Coronavirus DFCs as part of our Research and Development Day and expect to announce a development candidate for our CD73 oncology program by the end of 2022.~~confirmed efficacy seen in early analyses:

Janssen Collaboration Agreement

On March 31, 2021, we entered into ~~the~~an exclusive, worldwide license and collaboration agreement, or the Janssen Collaboration Agreement, with Janssen Pharmaceuticals, Inc., or Janssen, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize one or more DFCs based on our Cloudbreak platform for the prevention and treatment of influenza.

Under the terms of the Janssen Collaboration Agreement, we are collaborating in the research, preclinical and early clinical development of CD388, under a mutually-agreed research plan with the objective of advancing development through Phase 1 clinical trials and the first Phase 2a clinical trial. We are responsible for performing all IND-enabling nonclinical studies and early-stage clinical trials under the research plan. Both parties are responsible for conducting certain specified chemistry, manufacturing and controls, or CMC, development activities under the research plan. Janssen is solely responsible, and reimburses us for internal personnel and out-of-pocket costs incurred in performing the research plan activities in accordance with an agreed budget. ~~After completion~~As part of ~~the research plan and upon~~a recent prioritization of its ~~election~~R&D business, in July 2023 Janssen disclosed its intention to ~~proceed with~~discontinue internal development of multiple product candidates in its infectious disease pipeline, including CD388. However, in September 2023 Janssen delivered its Election to Proceed Notice for CD388 whereby Janssen will ~~be solely responsible for late-stage~~assume the future development, manufacturing ~~licensure~~ and ~~commercialization.~~ commercialization activities of CD388 but intends to transfer its rights and obligations under the Janssen Collaboration Agreement to another transferee. We continue to work in collaboration with Janssen to complete the Phase 1 and Phase 2a clinical trials and will be reimbursed for all ongoing development activities by Janssen as per the Janssen Collaboration Agreement.

Upon the effectiveness of the Janssen Collaboration Agreement, Janssen paid us an upfront payment of $27.0 million. As of the execution of the Janssen Collaboration Agreement, we ~~are~~were eligible for reimbursement by Janssen of up to $58.2 million in research and development costs incurred in conducting research plan activities. As of September 30, ~~2022,~~2023, we have received the $27.0 million up-front payment, ~~$20.6~~$41.6 million in research and development reimbursements, and ~~$3.0~~$10.0 million in milestone payments.

We are eligible to receive up to an additional ~~$237.0~~$230.0 million in development and regulatory milestone payments from Janssen for successful completion of certain activities over the next several years, including but not limited to ~~Janssen's~~Janssen’s decision whether to proceed with clinical development and initiation of ~~a pivotal trial.~~Phase 2b and Phase 3 trials. In addition, we may be eligible to receive approximately $455.0 million in commercial milestones as well as royalties on tiers of annual net sales at rates from the mid-single digits to the high-single digits.

Cloudbreak Oncology Programs

We have expanded the Cloudbreak platform beyond infectious diseases, to discover and develop highly potent DFCs that can target multiple immune checkpoint pathways with a single DFC for oncologic diseases.

Immune checkpoint antagonists have generated durable responses in cancers with improved side effect profiles compared to conventional chemotherapy. However, to date, improved outcomes from existing therapies have been limited to a relatively small subset of patients. To broaden the response rate to more patients, targeting additional mechanisms of tumor immune evasion will be critical.

Cloudbreak Oncology seeks to develop a new generation of immunotherapies targeting the tumor microenvironment. Our lead oncology DFC candidate, CBO421, is a potential best-in-class CD73 inhibitor that combines the strengths of small molecules and monoclonal antibodies targeting CD73. CBO421 targets CD73 in the adenosine pathway, which contributes to immune evasion in solid cancers by flooding the tumor microenvironment with adenosine, a potent immune cell suppressor. The CD73 pathway is clinically validated in early/mid-stage clinical studies to reduce tumor growth in combination with PD-1/ PD-L1 inhibitors in disease areas that do not historically respond to checkpoint inhibition alone, such as advanced colorectal cancer, or CRC, and non-small cell lung cancer, or NSCLC. As a monotherapy and in combination with PD-1 inhibitors, CBO421 has demonstrated formation of immunologic memory in multiple murine tumor models, along with potential best-in-class activity in T-cell reactivation assays and tumor penetration compared with the most advanced CD73 antibody therapeutics in clinical development. We are currently advancing CBO421 through IND-enabling studies and expect to file an IND in mid-2024.

In February 2023, we expanded our existing collaboration with WuXi XDC, a leading global contract manufacturing organization dedicated to end-to-end bioconjugates services, under which WuXi XDC will provide IND-enabling CMC development services for our Cloudbreak Oncology program.

CBO421 demonstrates outstanding preclinical performance:

CBO421 enhances anti-tumor activity of PD-1 inhibitors:

CBO421 and Anti-PD-1 combination improves response rates versus monotherapies.

CD73/PD-1 DFC potently inhibits both PD-1 and CD73 receptors:

Enhancement of activity in preclinical models observed when CBO421 was combined with PD-1 inhibition inspired the development of a first in class multispecific CD73/PD-1 targeting DFC that potently inhibits both targets simultaneously. Emerging preclinical data is promising. The multispecific DFC retains the full activity of the monotherapy components in functional binding and activity assays. In a murine colorectal carcinoma efficacy model, the multispecific DFC exhibited superior activity compared with CBO421 and the marketed PD-1 inhibitor, pembrolizumab, validating the concept. Optimization and preclinical development of our CD73/PD-1 targeting DFCs is ongoing.

CD73/PD-1 DFC outperforms monotherapies in humanized tumor models:

CCRs are a historically difficult-to-drug receptor family:

The DFC platform is also being expanded to include a validated, but difficult class of targets to drug, the chemokine receptors, or CCRs. CCR5 is a validated oncology target that can be a major driver in cancers that rely on the CCL5/CCR5 signaling pathway (e.g., breast, pancreatic and renal cell carcinomas). In several cancers, tumors secrete chemokine CCR5 agonists that promote tumor growth, metastasis and chemoresistance, while simultaneously recruiting immuno-suppressive macrophages and myeloid derived suppressor cells, or MDSCs, to the tumor microenvironment. We have rapidly been able to advance highly potent lead DFC CCR5-antagonist drug candidates that demonstrate robust activity as monotherapies in murine colorectal carcinoma models. Further optimization and preclinical characterization of our CCR5-DFC lead candidates including combination therapy studies, is ongoing.

CCR5-DFC shows strong tumor control in preclinical model:

Rezafungin

Rezafungin is a novel molecule in the echinocandin class of antifungals. We are developing rezafungin for the ~~first-line~~ treatment and prevention of serious, invasive fungal infections which are associated with high mortality rates.

~~ReSTORE Phase 3 clinical trial~~FDA Approval of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis

In ~~December 2021, we reported positive topline results from ReSTORE, our Phase 3 pivotal clinical trial~~March 2023, the FDA approved REZZAYO (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia ~~and/or~~and invasive candidiasis ~~(NCT03667690). ReSTORE was~~in over a ~~global, randomized, double-blind, controlled trial evaluating~~decade, and is the ~~efficacy~~only available once-weekly echinocandin.

Positive CHMP Opinion for Rezafungin for the Treatment of Invasive Candidiasis in Adults

The EMA accepted the marketing authorization application, or MAA, for rezafungin in August 2022. On October 12, 2023, Cidara and ~~safety of~~Mundipharma, which has commercial rights to rezafungin asoutside the U.S. and Japan, received a ~~potential first-line treatment~~positive opinion from the EMA’s CHMP for ~~candidemia and invasive candidiasis. ReSTORE enrolled 187 patients and evaluated one 400 milligram, or mg, loading dose of~~ rezafungin for the ~~first week followed~~treatment of invasive candidiasis in adults. The EC will review the CHMP recommendation and is expected to make a final decision on approval by ~~200 mg~~the end of ~~rezafungin dosed once-weekly for up to four weeks~~2023.

REZZAYO Commercialization in ~~total. The treatment arm was compared to approved daily dosing~~the U.S. by Melinta

On July 31, 2023, Melinta initiated the commercial launch of ~~caspofungin~~REZZAYO in ~~a 1:1 randomization.~~

~~Results from~~ the ReSTORE trial showed that rezafungin met the primary endpoint for the FDA NDA submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency, or EMA, Marketing Authorization Application, submission of global cure at Day 14. Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly, versus caspofungin dosed once-daily, the current standard of care.U.S.

ReSPECT Phase 3 clinical trial

We are currently conducting the ReSPECT, single, global, randomized, double-blind, controlled Phase 3 pivotal clinical trial (NCT04368559) in patients undergoing allogeneic blood and marrow transplant to assess rezafungin in a 90-day prophylaxis regimen to prevent infections due to Candida, Aspergillus and Pneumocystis. Rezafungin, dosed at 400 mg for the first week followed by 200 mg once weekly out to 90 days, is being compared to a regimen containing two drugs (an azole and Bactrim) dosed once daily for 90 days. The primary efficacy outcome for this trial for the FDA and EMA is fungal-free survival at ~~day~~Day 90. We expect this trial to enroll approximately 462 patients. ~~While~~A blinded interim analysis is planned in the ~~ReSPECT~~first quarter of 2024 which will inform the current fungal free survival rates, or FFS. The FFS will determine if the 462 patients planned to be enrolled will be sufficient to power the trial ~~remains open for enrollment, we continue~~ to ~~monitor the near- and long-term impact of COVID-19 on the ability of our clinical investigators to recruit patients at each of our global clinical trial sites. Thus far, we have relied on sites~~detect non-inferiority. The study is currently enrolling in the European Union, or EU, ~~for enrollment. Our first four~~Canada and the U.S. ~~sites have been recently activated and we are activating additional U.S. sites by year end.~~

Melinta License Agreement

On July 26, 2022, we entered into a License Agreement with Melinta, or the Melinta License Agreement, ~~with Melinta Therapeutics, LLC, or Melinta,~~ under which we granted Melinta an exclusive license to develop and commercialize products that contain or incorporate rezafungin in the U.S.

Melinta will be solely responsible for the commercialization of rezafungin in the U.S., at its sole expense. We ~~will be~~are responsible for conducting an agreed upon development plan that includes, among other activities, completion of the ongoing ReSPECT Phase 3 pivotal clinical trial for the prevention of invasive fungal infections in adult allogeneic blood and marrow transplant recipients. We will initially remain the holder of ~~all FDA submissions, including~~ the rezafungin

~~investigational~~ IND and new drug application, or ~~IND, and~~ NDA. ~~The FDA submissions~~Both regulatory applications will transfer to Melinta on a transfer date determined based on the status of the ReSPECT trial and the associated supplemental NDA, or sNDA, for the prophylaxis indication. Following the transfer date, we will remain financially responsible for post-marketing commitments and other remaining development obligations and the costs for those will be deducted from royalties owed to us by Melinta.

The total potential transaction value of the Melinta License Agreement is $460.0 million, including a $30.0 million upfront payment and up to $430.0 million in regulatory and commercial milestones. In addition, we are eligible ~~for~~to receive tiered royalties on U.S. sales in the low double digits to mid-teens. As of September 30, ~~2022,~~2023, we have received the $30.0 million up-front payment and a $20.0 million milestone payment.

Mundipharma Collaboration Agreement

On September 3, 2019, we announced a strategic partnership with Mundipharma to develop and commercialize rezafungin in an intravenous formulation for the treatment and prevention of invasive fungal infections. Under the terms of the Collaboration and License Agreement with Mundipharma, or the Mundipharma Collaboration Agreement, ~~with Mundipharma Medical Company, or Mundipharma,~~ we granted Mundipharma an exclusive, royalty-bearing license to develop, register and commercialize rezafungin outside the U.S. and Japan. The total potential transaction value is $568.4 million, including an equity investment, an up-front payment, global development funding, and certain development, regulatory, and commercial milestones. ~~The Company is~~We are also eligible ~~for~~to receive double-digit royalties in the teens on tiers of annual net sales.

As of September 30, ~~2022,~~2023, we have received $9.0 million from the sale of our equity to Mundipharma, a $30.0 million up-front payment, ~~$31.4~~$31.2 million in global development funding, and $25.1 million in milestone payments (including an $11.1 million milestone payment creditable against future royalties payable to us).

~~COVID-19 Update~~Compliance with Nasdaq Listing Requirements

~~We continue~~On February 9, 2023, we received formal notice from The Nasdaq Stock Market, LLC, or Nasdaq, Hearings Panel, or the Panel, stating that we have regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), subject to ~~monitor the potential impact~~a discretionary Panel Monitor until November 9, 2023.

Impact of the COVID-19 ~~global~~Pandemic and Other Macroeconomic Conditions

~~We are reliant on our information technology systems, infrastructure~~conduct of clinical trials and ~~data to conduct our business.~~other key activities and there is uncertainty regarding the potential resurgence of COVID-19. Adopting a work-from-home policy ~~during this pandemic~~ has increased the complexity of our computer systems, making them inherently more vulnerable to service interruption or destruction, malicious intrusion and random attack.

While we have not experienced significant disruptions to our manufacturing supply chain or distribution to date, we are unable to fully assess the potential impact that an extended duration of this pandemic may have on our manufacturing or distribution processes in the future.

AsWe may also be impacted by broader macroeconomic conditions, including high inflation, bank failures, labor shortages, supply chain disruptions, recession risks and potential disruptions from the ongoing Russia-Ukraine conflict and related sanctions. For example, the recent closures of Silicon Valley Bank, Signature Bank and First Republic Bank have resulted in broader financial institution liquidity risk and concerns. While we ~~continue~~do not have deposits with these banks, if other banks and financial institutions enter receivership or become insolvent in the future in response to ~~actively advance~~financial conditions affecting the banking system and financial markets, our ~~rezafungin Phase 3 clinical development program, we remain in close contact with~~ability to access our ~~principal investigators~~existing cash and ~~clinical sites and continue to monitor the impact of COVID-19~~cash equivalents may be threatened, which could have a material adverse effect on our trials, expected timelines and costs on an ongoing basis. While the ReSPECT Phase 3 clinical trial for prophylaxis remains open for enrollment, we continue to monitor the near- and long-term impact of COVID-19 on the ability of our clinical investigators to recruit patients at each of our global clinical trial sites.

~~The extent of the impact of COVID-19 on our operational~~business and financial ~~performance will depend on certain developments, including~~condition. The stock market, and in particular the ~~duration~~market for pharmaceutical and ~~spread~~biotechnology company stocks, has recently experienced significant decreases in value. This volatility and valuation decline have affected the market prices of ~~the outbreak, impact on our clinical trials, employees and vendors, all of which are uncertain and cannot be predicted. Given these uncertainties and new information that may continue~~securities issued by many companies, often for reasons unrelated to emerge about COVID-19 strains, the full extent of the impact of the COVID-19 pandemic cannot be accurately predicted at this time, and we remain unable to reasonably estimate the related impact to our business,their operating ~~results and financial condition, if any. We will continue to evaluate and actively monitor the impact of the COVID-19 pandemic on our business.~~performance.

Liquidity Overview

Since our inception, we have devoted substantially all of our financial resources and efforts to research and development and have incurred significant operating losses. As of September 30, ~~2022,~~2023, we had an accumulated deficit of ~~$393.6~~$424.3 million. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future.

In connection with the preparation of our financial statements for the three and nine month ~~period~~periods ended September 30, ~~2022,~~2023, we performed an analysis of our ability to continue as a going concern. We believe, based on our current business plan, that our existing cash and cash equivalents ~~may~~will not be sufficient to fund our obligations for ~~twelve months~~a period of one year from the issuance of these condensed consolidated financial ~~statements.~~statements, which raises substantial doubt about our ability to continue as a going concern. Our ability to execute our current business plan depends on our ability to obtain additional funding through equity offerings, debt ~~and other non-dilutive financing alternatives,~~financings or potential licensing and collaboration arrangements. We may not be able to raise additional funding on terms acceptable to us, or at all, and any failure to raise funds as and when needed will compromise our ability to execute on our business plan.

FINANCIAL OPERATIONS OVERVIEW

Revenues

To date, we have generated all of our revenues from our strategic partnerships with Mundipharma and Janssen, and our license ~~agreement~~and commercial supply agreements with Melinta. In the future, we may generate revenue from a combination of license fees and other upfront payments, other funded research and development agreements, milestone payments, product sales, government and other third-party funding and royalties in connection with strategic alliances. We expect that any revenue we generate will fluctuate from quarter-to-quarter as a result of the timing of our achievement of nonclinical, clinical, regulatory and commercialization milestones, the timing and amount of payments relating to such milestones and the extent to which ~~any of~~ our products are approved and successfully commercialized.

If we are unable to fund our development costs or we are unable to develop product candidates in a timely manner or obtain regulatory approval for them, our ability to generate future revenues and our results of operations and financial position would be adversely affected.

Research and development expenses

To date, our research and development expenses have related primarily to nonclinical development of our rezafungin acetate and our Cloudbreak platform, as well as clinical development of rezafungin acetate. Research and development expenses consist of wages, benefits and stock-based compensation for research and development employees, as well as the cost of scientific consultants, facilities and overhead expenses, laboratory supplies, manufacturing expenses in preclinical development and certain manufacturing expenses before FDA approval, and nonclinical and clinical trial costs. We accrue clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of studies or other activities within studies and other events.

Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of the study or project and the invoices received from our external service providers. We adjust our accruals as actual costs become known.

We may receive potential research and development funding through a partnership from the National Institute of Allergy and Infectious Diseases. We have evaluated the terms of the grants to assess our obligations and the classification of funding received. Amounts received for funded research and development are recognized in the ~~statement~~condensed consolidated statements of operations and comprehensive income (loss) as a reduction to research and development expense over the grant period as the related costs are incurred to meet our obligations.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase over the next several years as we continue to conduct nonclinical and clinical studies, expand our research and development pipeline and progress our product candidates through clinical trials. However, it is difficult to determine with certainty the duration, costs and timing to complete our current or future nonclinical programs and clinical trials of our product candidates.

The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the following:

•the impact of the COVID-19 pandemic and other similar health crises;

•per patient trial costs;

•the number of patients that participate in the trials;

•the number of sites included in the trials;

•the countries in which the trials are conducted;

•the length of time required to enroll eligible patients;

•the number of doses that patients receive;

•the drop-out or discontinuation rates of patients;

•potential additional safety monitoring or other studies requested by regulatory authorities;

•the duration of patient follow-up;

•the phase of development of the product candidate; and

•the efficacy and safety profile of the product candidates.

3038

Research and development expenses by major program or category were as follows (in thousands):


		Three Months Ended September 30,				Nine Months Ended September 30,					Three Months Ended September 30,				Nine Months Ended September 30,
		2022		2021		2022		2021			2023		2022		2023		2022
Rezafungin	Rezafungin	$	9,352	$	12,440	$	28,142	$	31,596	Rezafungin	$	5,207	$	9,352	$	18,866	$	28,142

Cloudbreak platform	Cloudbreak platform	6,252		3,296		12,734		8,283		Cloudbreak platform	7,544		6,252		20,370		12,734
Personnel costs	Personnel costs	3,881		4,231		12,741		12,586		Personnel costs	3,912		3,881		12,203		12,741
Other research and development expenses	Other research and development expenses	556		538		1,845		1,609		Other research and development expenses	667		556		1,741		1,845
Total research and development expenses	Total research and development expenses	$	20,041	$	20,505	$	55,462	$	54,074	Total research and development expenses	$	17,330	$	20,041	$	53,180	$	55,462

We typically deploy our employees, consultants and infrastructure resources across our programs. Thus, some of our research and development expenses are not attributable to an individual program but are included in other research and development expenses as shown above.

In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

General and administrative expenses

General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, legal, business development, commercial planning, and support functions. Other general and administrative expenses include facility and overhead costs not otherwise included in research and development expenses, consultant expenses, travel expenses and professional fees for auditing, tax, legal, and other services. We expect that general and administrative expenses will increase in the future as we expand our operating activities and incur additional costs associated with operating as a publicly traded company. These increases will likely include legal fees, accounting fees, directors’ and officers’ liability insurance premiums and costs associated with investor relations.

Other income, ~~(expense),~~ net

Other income, ~~and expense consist~~net consists primarily of interest income and expense, and various income or expense items of a non-recurring nature.

We earn interest income from interest-bearing accounts and money market funds for cash and cash equivalents. Interest expense represents interest ~~payable~~paid related to term loans and the amortization of debt issuance costs.

CRITICAL ACCOUNTING ESTIMATES

Our discussion and analysis of our financial condition and results of operations is based upon unaudited financial statements that we have prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these unaudited financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities as of the date of the financial statements, and the revenues and expenses incurred during the reporting periods. We believe that the estimates, judgments and assumptions are reasonable based upon information available to us at the time that these estimates, judgments and assumptions are made. To the extent there are material differences between these estimates, judgments or assumptions and actual results, our financial statements will be affected. Historically, revisions to our estimates have not resulted in a material change to our financial statements. While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements contained in our Annual Report, ~~on Form 10-K,~~ the significant accounting estimates that we believe are important to aid in fully understanding and evaluating our reported financial results include the following:

Revenue Recognition

We recognize revenue in accordance with ~~ASC~~Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, or Topic 606, which applies to all contracts with customers, except for elements of certain contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition

for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance

obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or service we transfer to a customer. At contract inception, once the contract is determined to be within the scope of Topic 606, we assess the goods or services promised within each contract and identify those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

In a contract with multiple performance obligations, we must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. We evaluate each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

Collaboration Revenue

If a license to our intellectual property is determined to be distinct from the other performance obligations identified in a contract, we recognize revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from the allocated transaction price. We evaluate the measure of progress at each reporting period and, if necessary, adjust the measure of performance and related revenue or expense recognition as a change in estimate.

At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being reached. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or a collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, we re-evaluate the probability of achievement of milestones that are within our or a collaboration partner’s control, such as operational development milestones and any related constraint, and, if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which will affect collaboration revenues and earnings in the period of adjustment. Revisions to our estimate of the transaction price may also result in negative collaboration revenues and earnings in the period of adjustment.

For arrangements that include sales-based royalties, including commercial milestone payments based on the level of sales, and a license is deemed to be the predominant item to which the royalties relate, we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied, or partially satisfied. To date, we have not recognized any royalty revenue from collaborative arrangements.

In September 2019, we entered into the Mundipharma Collaboration Agreement with Mundipharma. We concluded that there were three performance obligations under the Mundipharma Collaboration Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. ~~Revenue associated with the license was recognized upon delivery in September 2019.~~

In March 2021, we entered into the Janssen Collaboration Agreement with Janssen. We concluded that there were three performance obligations under the Janssen Collaboration Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. ~~Revenue associated with the license was recognized upon delivery in May 2021.~~

In July 2022, we entered into the Melinta License Agreement with Melinta. We concluded that there were three performance obligations under the Melinta License Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. ~~Revenue associated with the license was recognized upon delivery in August 2022.~~

We concluded that progress towards completion of the research and development and clinical supply performance obligations related to the Mundipharma Collaboration Agreement ~~as well as progress towards completion of the research~~ and ~~development performance obligation related to~~ the Melinta License Agreement, are best measured in an amount proportional to the collaboration expenses incurred and the total estimated collaboration expenses. We periodically review and update the estimated collaboration expenses, when appropriate, which may adjust revenue recognized for the period. While such changes to our estimates have no impact on our reported cash flows, the amount of revenue recorded in the

period could be materially impacted. Revenue for the Janssen Collaboration Agreement is recognized based on actual amounts billed as the underlying services are provided and billed at market rates. The transaction prices to be recognized as revenue under both the Mundipharma Collaboration Agreement and the Janssen Collaboration Agreement consist of upfront payments, estimated reimbursable research and development and clinical

supply costs, and milestones achieved to date. The transaction price to be recognized as revenue under the Melinta License Agreement consists of an upfront ~~payment.~~payment and milestones achieved to date.

See Note 78 to the financial statements for additional information.

~~Research~~Product Revenue

In December 2022 and ~~Development Costs~~January 2023, we entered into separate Commercial Supply Agreements with Mundipharma and Melinta, respectively, for the batch supply of REZZAYO naked vials for commercial use. Under the Commercial Supply Agreements, Mundipharma and Melinta are required to submit purchase orders to us for batches of REZZAYO naked vials. We concluded that the delivery of each batch of REZZAYO naked vials and the related quality assessment certification represents a distinct performance obligation.

~~Research and development expenses consist~~The transaction price to be recognized as revenue for each performance obligation under the Commercial Supply Agreements consists of wages, benefits and stock-based compensation charges for research and development employees, scientific consultant fees, facilities and overhead expenses, laboratory supplies, manufacturing expenses, and nonclinical and clinical trial costs. We accrue nonclinical and clinical trial expensesvariable consideration which is determined based on ~~work performed, which relies~~the estimated per vial costs, plus the contractually stated margin rate. The amounts recognized as revenue are adjusted, as needed, each reporting period based on ~~estimates of total~~actual costs incurred ~~based on patient enrollment,~~for each batch. Variable consideration is included in the transaction price only to the extent that it is considered probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price will be fully allocated to the single performance obligation.

We concluded that the performance obligation is satisfied and product revenue is recognized when the customer obtains control of the product, which occurs at a point in time, typically upon the later of (i) completion of ~~studies,~~a positive quality assessment, or (ii) shipment of our product to the customer.

Shipping and ~~other events. We periodically confirm~~handling activities that are performed after a customer obtains control of the ~~accuracy~~product are treated as activities to fulfill the promise to a customer and any amounts billed to a customer represent revenues for the product provided. Costs related to such shipping and handling billings are classified as cost of ~~these estimates with our service providers and make adjustments if necessary.~~

Preclinical and Clinical Trial Accruals

We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on the facts and circumstances known to us at that time. Our accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations, or CROs, clinical trial investigational sites and other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones. In accruing for these services, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from these service providers. However, we may be required to estimate these services based on other information available to us. If we underestimate or overestimate the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in our accruals.

~~Stock-Based Compensation~~

We account for stock-based compensation expense related to stock options, restricted stock units, or RSUs, performance RSUs, or PRSUs, and employee stock purchase plan, or ESPP, rights by estimating the fair value on the date of grant. We estimate the fair value of stock options granted to employees and non-employees using the Black-Scholes option pricing model. The fair value of RSUs and PRSUs granted to employees is estimated based on the closing price of our common stock on the date of grant.

The assumptions included in the Black-Scholes option pricing model include (a) the risk-free interest rate, (b) the expected volatility of our stock, (c) the expected term of the award, and (d) the expected dividend yield. We computed the historical volatility data using the daily close prices for our common stock during the equivalent period of the calculated expected term of our stock-based awards. We estimated the expected life of employee stock options using the “simplified” method, whereby the expected life equals the average of the vesting term and the original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are based on the yields of zero-coupon U.S. treasury securities. The expected dividend yield of zero reflects that we have not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future.

For awards subject to time-based vesting conditions, including those with a graded vesting schedule, stock-based compensation expense is recognized using the straight-line method. For performance-based awards to employees, (i) the fair value of the award is determined on the grant date, (ii) we assess the probability of the individual performance milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met.

We recognize forfeitures related to stock-based compensation as they occur and any compensation cost previously recognized for awards for which the requisite service has not been completed is reversed in the period that the award is forfeited.

RESULTS OF OPERATIONS

Comparison of the three months ended September 30, ~~2022~~2023 and ~~2021~~2022

The following table summarizes our results of operations for the three months ended September 30, ~~2022~~2023 and ~~2021~~2022 (in thousands):


		Three Months Ended September 30,							Three Months Ended September 30,
		2022		2021		Change			2023		2022		Change
Collaboration revenue	Collaboration revenue	$	40,744	$	7,076	$	33,668	Collaboration revenue	$	11,250	$	40,744	$	(29,494)
Product revenue								Product revenue	1,468		—		1,468
Cost of product revenue								Cost of product revenue	387		—		387
Research and development expense	Research and development expense	20,041		20,505		(464)		Research and development expense	17,330		20,041		(2,711)
General and administrative expense	General and administrative expense	5,780		4,607		1,173		General and administrative expense	3,556		5,780		(2,224)
Other income (expense), net		55		(47)		102
Other income, net								Other income, net	613		55		558
Income tax expense								Income tax expense	(230)		—		(230)

Collaboration revenue

Collaboration revenue was $11.3 million for the three months ended September 30, 2023 and $40.7 million for the three months ended September 30, ~~2022 and $7.1 million~~2022. Revenue for the three months ended September 30, ~~2021.~~ 2023 related to the achievement of a milestone, ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $1.6 million, $9.2 million and $0.4 million, respectively, as well as $0.1 million in royalty revenue recognized following initiation of the commercial launch of REZZAYO in the U.S. on July 31, 2023.

Revenue for the three months ended September 30, 2022 included $25.9 million of revenue recognized upon transfer of an intellectual property license to Melinta in August 2022. The remaining revenue for the three months ended September 30, 2022 ~~relates~~related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $8.0 million, $6.5 million and $0.3 million, respectively.

~~Revenue~~Product revenue

Product revenue was $1.5 million for the three months ended September 30, ~~2021 relates~~2023 and related to ~~ongoing~~shipment of REZZAYO naked vials to Melinta. REZZAYO received approval by the FDA and was launched commercially in the U.S. by Melinta on July 31, 2023.

Cost of product revenue

Cost of product revenue was $0.4 million for the three months ended September 30, 2023 and primarily consisted of direct material costs, third-party manufacturing costs and indirect overhead costs associated with the manufacture, quality assessment and delivery of REZZAYO naked vials shipped to Melinta. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development ~~and clinical supply services provided to Mundipharma and Janssen of $3.3 million and $3.8 million, respectively.~~expense in the period incurred.

Research and development expenses

Research and development expenses were $17.3 million for the three months ended September 30, 2023 and $20.0 million for the three months ended September 30, ~~2022 and $20.5 million for the three months ended September 30, 2021.~~2022. The decrease in research and development expenses is primarily due to lower clinical expenses associated with the rezafungin clinical trials, ~~and lower consulting and personnel costs,~~ offset by higher clinical expenses associated with our Cloudbreak ~~antiviral platform.~~platform and higher personnel costs.

General and administrative expenses

General and administrative expenses were $3.6 million for the three months ended September 30, 2023 and $5.8 million for the three months ended September 30, ~~2022 and $4.6 million for the three months ended September 30, 2021.~~2022. The ~~increase~~decrease in general and administrative expenses is primarily due to lower consulting, personnel and legal costs, and lower amortization of contract costs related to obtaining the Melinta License ~~Agreement offset by lower consulting and personnel costs.~~Agreement.

Other income, ~~(expense),~~ net

Other income, ~~(expense),~~net during the three months ended September 30, 2023 related primarily to interest income generated from cash held in interest-bearing accounts. Other income, net during the three months ended September 30, 2022 ~~and September 30, 2021~~ related primarily to interest income generated from cash held in interest-bearing accounts, offset by interest expense in connection with our loan from Pacific Western ~~Bank,~~Bank.

Income tax expense

Income tax expense for the three months ended September 30, 2023 is primarily the result of capitalized Internal Revenue Code, or IRC, Section 174 research and development expenditures, effective January 1, 2022, creating taxable income which can be partially offset with net operating losses and credits that are limited in use by ~~interest income generated from cash held in interest-bearing investments.~~

IRC Sections 382 and 383.

Comparison of the nine months ended September 30, ~~2022~~2023 and ~~2021~~2022

The following table summarizes our results of operations for the nine months ended September 30, ~~2022~~2023 and ~~2021~~2022 (in thousands):


		Nine Months Ended September 30,						Nine Months Ended September 30,
		2022		2021	Change			2023		2022		Change
Collaboration revenue	Collaboration revenue	$	54,069	42,347	$	11,722	Collaboration revenue	$	44,854	$	54,069	$	(9,215)
Product revenue							Product revenue	1,468		—		1,468
Cost of product revenue							Cost of product revenue	387		—		387
Research and development expense	Research and development expense	55,462		54,074	1,388		Research and development expense	53,180		55,462		(2,282)
General and administrative expense	General and administrative expense	15,058		13,758	1,300		General and administrative expense	11,164		15,058		(3,894)
Other expense, net		29		(179)	208
Other income, net							Other income, net	1,468		29		1,439
Income tax expense							Income tax expense	(379)		—		(379)

Collaboration revenue

Collaboration revenue was $44.9 million for the nine months ended September 30, 2023 and $54.1 million for the nine months ended September 30, ~~2022 and $42.3 million~~2022. Revenue for the nine months ended September 30, ~~2021.~~ 2023 related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $5.1 million, $20.5 million and $19.1 million, respectively, as well as $0.1 million in royalty revenue recognized following initiation of the commercial launch of REZZAYO in the U.S. on July 31, 2023.

Revenue for the nine months ended September 30, 2022 included $25.9 million of revenue recognized upon transfer of an intellectual property license to Melinta in August 2022. The remaining revenue for the nine months ended September 30, 2022 ~~relates~~related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $12.5 million, $15.4 million and $0.3 million, respectively.

~~Revenue~~Product revenue

Product revenue was $1.5 million for the nine months ended September 30, ~~2021 included $27.0~~2023 and related to shipment of REZZAYO naked vials to Melinta. REZZAYO received approval by the FDA and was launched commercially in the U.S. by Melinta on July 31, 2023.

Cost of product revenue

Cost of product revenue was $0.4 million ~~of revenue recognized upon transfer of an intellectual property license to Janssen in May 2021. The remaining revenue~~ for the nine months ended September 30, ~~2021 relates~~2023 and primarily consisted of direct material costs, third-party manufacturing costs and indirect overhead costs associated with the manufacture, quality assessment and delivery of REZZAYO naked vials shipped to ~~ongoing~~Melinta. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development ~~and clinical supply services provided to Mundipharma and Janssen of $8.4 million and $6.9 million, respectively.~~expense in the period incurred.

Research and development expenses

Research and development expenses were $53.2 million for the nine months ended September 30, 2023 and $55.5 million for the nine months ended September 30, ~~2022 and $54.1 million for the nine months ended September 30, 2021.~~2022. The ~~increase~~decrease in research and development expenses is primarily due to ~~increased expense associated with our Cloudbreak antiviral platform and higher personnel costs, offset by~~ lower clinical expenses associated with the rezafungin clinical ~~trials.~~trials and lower consulting and personnel costs, offset by higher clinical expenses associated with our Cloudbreak platform.

General and administrative expenses

General and administrative expenses were $11.2 million for the nine months ended September 30, 2023 and $15.1 million for the nine months ended September 30, ~~2022 and $13.8 million for the nine months ended September 30, 2021.~~2022. The ~~increase~~decrease in general and administrative expenses is primarily due to lower consulting, personnel and legal costs, and lower amortization of contract costs related to obtaining the Melinta License ~~Agreement, offset by lower consulting and personnel costs.~~Agreement.

Other income, ~~(expense),~~ net

Other income, ~~(expense),~~net during the nine months ended September 30, 2023 related primarily to interest income generated from cash held in interest-bearing accounts. Other income, net during the nine months ended September 30, 2022 ~~and September 30, 2021~~ related primarily to interest income generated from cash held in interest-bearing accounts, offset by interest expense in connection with our loan from Pacific Western ~~Bank,~~Bank.

Income tax expense

Income tax expense for the nine months ended September 30, 2023 is primarily the result of capitalized IRC Section 174 research and development expenditures, effective January 1, 2022, creating taxable income which can be partially offset with net operating losses and credits that are limited in use by ~~interest income generated from cash held in interest-bearing investments.~~IRC Sections 382 and 383.

LIQUIDITY AND CAPITAL RESOURCES

Our primary sources of liquidity are our cash and cash equivalents, as well as the cash flows generated from our partnerships with Mundipharma and Janssen, our license to Melinta, and equity and debt financings. We have devoted our resources to funding research and development programs, including research, preclinical and clinical development activities.

Our ability to fund future operating needs will depend on a combination of equity, debt or other financing structures, receipt of payments under the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement, as well as potentially entering into other collaborations, strategic alliances or licensing arrangements with third parties or receiving government and/or charitable grants or contracts. Our ability to raise additional capital may also be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the U.S. and worldwide ~~resulting~~ from geopolitical and macroeconomic events, including the COVID-19 pandemic, the ongoing ~~COVID-19 pandemic.~~

Russia-Ukraine conflict and related sanctions, and bank failures.

We are eligible to receive up to $484.3 million in development, regulatory and commercial milestone payments from Mundipharma for successful completion of certain activities over the next several years, as well as double-digit royalties in the teens on tiers of annual net sales.

We are eligible to receive up to ~~$237.0~~$230.0 million in development and regulatory milestone payments from Janssen for successful completion of certain activities over the next several years, including but not limited to ~~Janssen's~~Janssen’s decision to proceed with clinical development and initiation of a pivotal trial. In addition, we may be eligible to receive approximately $455.0 million in commercial milestones as well as royalties on tiers of annual net sales at rates from the mid-single digits to the high-single digits.

We are eligible to receive up to ~~$430.0~~$410.0 million in regulatory and commercial milestone payments from Melinta for successful completion of certain activities over the next several years, as well as tiered royalties on U.S. sales in the low double digits to mid-teens.

On November 8, 2018, we entered into the controlled equity offering sales agreement with Cantor Fitzgerald & ~~Co,~~Co., or the Sales Agreement, pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million. As of September 30, ~~2022,~~2023, the ~~aggregate offering price~~ remaining capacity under the Sales Agreement was ~~$46.8~~$37.1 million.

In March 2023, we issued shares of our common stock and Series X Convertible Preferred Stock upon the closing of concurrent but separate public offerings, for gross proceeds of approximately $19.5 million.

As of the date of this report, we have no outstanding loan balances.

Our lease with Nancy Ridge Technology Center, L.P. expires on December 31, ~~2023~~2026 with options for two individual two-year extensions, which have not been exercised, and remain in effect and available to the Company. As of September 30, ~~2022,~~2023, the Company was not reasonably certain that it would exercise the extension options, and therefore did not include these options in the determination of the total lease term for accounting purposes. Total undiscounted operating lease payments are ~~$1.7~~$5.3 million as of September 30, ~~2022.~~2023.

As discussed further below, we believe that our existing cash and cash equivalents will not be sufficient to fund our obligations for the next twelve ~~months.~~months, or beyond. There are many factors that could impact our operating cash flow, most notably achievement of milestones under our Mundipharma Collaboration Agreement, Janssen Collaboration Agreement and Melinta License Agreement. Our current cash balance and eligibility to potentially receive non-dilutive capital of up to approximately $40.1 million in development and regulatory milestones from our existing partnerships, contingent on successful completion of activities planned over the next eighteen months, has the potential to extend our cash runway in the near-term. There can be no assurance that we will be successful in completing all or part of the activities planned over the next twelve months which may adversely impact and reduce the amount of non-dilutive capital that we are eligible to receive from these activities.

We are mindful that conditions in the current macroeconomic environment could affect our ability to achieve our goals. We operate and conduct clinical trials in countries that face economic volatility and weakness. Sustained weakness or further deterioration of the local economies and currencies and adverse effects of the impact of the ~~ongoing~~ COVID-19 pandemic may pose operational challenges in those countries. We will continue to monitor these conditions and will attempt to adjust our business plans, as appropriate, to mitigate macroeconomic risks.

We enter into contracts in the normal course of business with vendors for research and development activities, manufacturing, and professional services that generally provide for termination either on notice or after a notice period. Our material cash requirements include costs to complete agreed-upon activities under our Mundipharma Collaboration Agreement, Janssen Collaboration Agreement and Melinta License Agreement, as well as personnel and general and administrative support costs.

As of September 30, ~~2022,~~2023, we had ~~$53.1~~$48.7 million in cash and cash equivalents. The following table shows a summary of our cash flows for the nine months ended September 30, ~~2022~~2023 and ~~2021~~2022 (in thousands):


		Nine Months Ended September 30,					Nine Months Ended September 30,
		2022		2021			2023		2022
Net cash (used in) provided by:	Net cash (used in) provided by:					Net cash (used in) provided by:
Operating activities	Operating activities	$	(7,471)	$	(10,325)	Operating activities	$	(9,710)	$	(7,471)
Investing activities	Investing activities	(109)		(41)		Investing activities	(327)		(109)
Financing activities	Financing activities	(1,615)		7,722		Financing activities	25,976		(1,615)
Net decrease in cash, cash equivalents, and restricted cash		$	(9,195)	$	(2,644)
Net increase (decrease) in cash and cash equivalents						Net increase (decrease) in cash and cash equivalents	$	15,939	$	(9,195)

Operating activities

Net cash used in operating activities was $9.7 million for the nine months ended September 30, 2023, compared to net cash used in operating activities of $7.5 million for the nine months ended September 30, ~~2022, compared to net cash~~2022. Cash used in operating activities ~~of $10.3 million~~ for the nine months ended September 30, ~~2021.~~2023 was primarily attributable to a net loss of $17.3 million. Cash used in operating activities for the nine months ended September 30, 2022 was primarily attributable to a net loss of $16.4 million, and included $2.8 million for a milestone achieved in December 2021 under the Mundipharma Collaboration Agreement, which was received in January 2022, $3.0 million for a milestone achieved in March 2022 under the Janssen Collaboration Agreement, which was received in May 2022, $11.1 million for a milestone achieved in August 2022 under the Mundipharma Collaboration Agreement, which was received in September 2022, and the $30.0 million upfront payment received in August 2022 pursuant to the Melinta License Agreement.

Cash used in operating activities for the nine months ended September 30, 2021 was primarily attributable to a net loss of $25.7 million and included $11.1 million for a milestone achieved in November 2020 under the Mundipharma Collaboration Agreement, which was received in January 2021, and the $27.0 million upfront payment received in May 2021 pursuant to the Janssen Collaboration Agreement.million.

For all periods presented, the primary use of cash was to fund research and development activities for our product candidates, which activities and uses of cash we expect to continue to increase for the foreseeable future.

Investing activities

Our investing activities during the nine months ended September 30, ~~2022~~2023 and ~~2021~~2022 consisted of purchases of property and equipment.

Financing activities

Net cash provided by financing activities during the nine months ended September 30, 2023 primarily consisted of (i) net proceeds of $17.3 million from the sale of 11,086,000 shares of common stock and 286,000 shares of Series X Convertible Preferred Stock pursuant to concurrent but separate underwritten public offerings and (ii) net proceeds of $8.7 million from the sale of 6,231,741 shares of common stock under the Sales Agreement, after deducting placement agent fees.

Net cash used in financing activities during the nine months ended September 30, 2022 primarily consisted of net proceeds of $1.7 million from the sale of 2,292,543 shares of common stock under the Sales Agreement, after deducting placement agent fees, offset by principal payments of $2.6 million made in connection with our loan from Pacific Western Bank and $0.7 million related to issuance costs for our 2021 underwritten public offering.

Net cash provided by financing activities during the nine months ended September 30, 2021 primarily consisted of net proceeds of $11.0 million from the sale of 4,577,115 shares of common stock under the Sales Agreement, after deducting placement agent fees, offset by principal payments of $3.3 million made in connection with our loan from Pacific Western Bank.

Operating Capital Requirements

We performed an analysis of our ability to continue as a going concern. We believe, based on our current business plan, that our existing cash and cash equivalents will not be sufficient to fund our obligations for the next twelve ~~months.~~months, which raises substantial doubt about our ability to continue as a going concern. Our ability to execute our operating plan depends on our ability to obtain additional funding through equity offerings, debt financings or potential licensing and collaboration arrangements. We plan to continue to fund our losses from operations through cash and cash equivalents on hand, as well as through future equity offerings, debt financings, other third party funding, and potential licensing or collaboration arrangements. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to us. Even if we raise additional capital, we may also be required to modify, delay or abandon some of our plans which could have a material adverse effect on our business, operating results and financial condition and our ability to achieve our intended business objectives. Any of these actions could materially harm our business, results of operations and future prospects.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a smaller reporting company, we are not required to provide information typically disclosed under this item.

ITEM 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

As of September 30, ~~2022,~~2023, we ~~are continuing to carry~~carried out an evaluation under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were ~~not~~ effective at the reasonable assurance level as of September 30, ~~2022 due to a material weakness in internal control over financial reporting described below.~~2023.

Changes in Internal Control over Financial Reporting

An evaluation was also performed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of any change in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. That evaluation did not identify any change in our internal control over financial reporting that occurred during our latest fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

~~Material Weakness in Internal Control Over Financial Reporting~~

We determined that our review control over the evaluation of applicable accounting standards and assessment of completeness and accuracy of valuation assumptions, related to non-routine transactions that include collaboration revenue, was not appropriately designed or operating effectively. While this improper design and operation did not result in a material error in the annual or interim financial statements, there is a reasonable possibility that a material misstatement in the annual or interim financial statements would not have been detected. Based on these factors, we concluded that the control deficiency noted above represents a material weakness.

A material weakness, as defined in Rule 12b-2 under the Exchange Act, is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected on a timely basis.

~~Remediation of Material Weakness~~

We are committed to maintaining a strong internal control environment and implementing measures to ensure that the control deficiency identified above is remediated as soon as possible. Management is in the process of implementing a remediation plan, which includes adding additional layers of review by members of our management team regarding the evaluation of applicable accounting standards and completeness and accuracy of valuation assumptions related to non-routine transactions that include collaboration revenue. The remediation actions are also being monitored by the Audit Committee of our Board of Directors.

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PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

None.

ITEM 1A. RISK FACTORS

Risk Factor Summary

Below is a summary of the principal factors that make an investment in our securities speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below and should be carefully considered.

•~~Our operations, business~~We need substantial additional funding to complete the development of rezafungin and ~~financial results have been~~to advance CD388, CBO421 and ~~could continue to be adversely impacted by the current public health pandemic related to COVID-19.~~our other Cloudbreak programs.

•We depend heavily on the success of rezafungin ~~for~~and CD388, which ~~an NDA has been submitted to the FDA, and CD388,~~are currently in Phase 1 and Phase 2a clinical development, and we are very early in our efforts to develop other product candidates from our Cloudbreak program, none of which may be successful.

•If we experience delays or difficulties in enrolling patients in our clinical trials our receipt of necessary regulatory approvals could be delayed or prevented.

•If clinical trials for rezafungin, CD388, CBO421 or any other product candidates are delayed, terminated or suspended, or fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, we may incur additional costs, or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

•If serious adverse reactions or unexpected characteristics of our product candidates are identified during development, we may need to abandon or limit our development of some or all of our product candidates.

•~~Even if any~~Any of our product candidates that receive marketing approval ~~they~~ may fail to achieve the degree of market acceptance by physicians, patients, formulary committees, third-party payors and others in the medical community necessary for commercial success.

•If, in the future, we are unable to establish sales and marketing capabilities or to selectively enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing our product candidates, if and when they are approved.

•We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

•We may not be successful in our efforts to identify, discover, and develop potential product candidates through our Cloudbreak platform or otherwise.

•~~We need substantial additional funding to complete the development of rezafungin and to advance CD388 and our Cloudbreak program.~~

•We are dependent on our collaboration partners to provide funding to continue the development of rezafungin and CD388; for the commercialization of rezafungin outside Japan; and for the late-stage development, manufacturing, registration and commercialization of CD388. If the collaborations are not successful, we may not be able to complete the development of rezafungin and CD388, or capitalize on the full market potential for rezafungin and CD388.

•We have no experience manufacturing product candidates on a clinical or commercial scale and will be dependent on third parties for the manufacture of our product candidates. If we experience problems with any of these third parties, they could delay clinical development or marketing approval of our product candidates or our ability to sell any approved products.

•If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, our product candidates and our ability to generate revenue will be impaired.

•Any product candidate for which we obtain marketing approval could be subject to marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.

•If we are unable to generate revenues from partnerships, government funding or other sources of funding, we may be forced to suspend or terminate one or more of our preclinical Cloudbreak programs.

•The price of our stock may be volatile, and you could lose all or part of your investment.

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Risk Factors

You should carefully consider the following risk factors, as well as the other information in this Quarterly Report, before deciding whether to purchase, hold or sell shares of our common stock. The occurrence of any of the following risks could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time. When evaluating our business, you should consider all of the factors described as well as the other information in our Annual Report, including our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The risk factors set forth below that are marked with an asterisk (*) contain changes to the similarly titled risk factors included in Item 1A of our Annual Report. If any of the following risks actually occurs, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock would likely decline and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Risks Related to Our Financial Position and Need for Additional Capital

We need substantial additional funding to complete the ~~COVID-19 Pandemic~~development of rezafungin and to advance CD388, CBO421 and our other Cloudbreak programs.*

In connection with the preparation of our financial statements for the period ended September 30, 2023, we performed an analysis of our ability to continue as a going concern. We believe, based on our current business plan, that our existing cash and cash equivalents will not be sufficient to fund our obligations for the next twelve months, which raises substantial doubt about our ability to continue as a going concern. Our ability to continue to fund the development of rezafungin through completion of our planned Phase 3 trials depends on our ability to obtain additional funding. Our ability to advance CD388, CBO421 and other product candidates from our other Cloudbreak programs is also dependent on our ability to obtain additional funding.

On September 3, 2019, we entered into a Collaboration and License Agreement, or the Mundipharma Collaboration Agreement, with Mundipharma Medical Company, or Mundipharma, pursuant to which we granted Mundipharma exclusive commercialization rights to rezafungin outside the United States, or U.S., and Japan in exchange for a $30.0 million upfront payment, near-term funding to support the global Phase 3 ReSTORE and ReSPECT trials, and the potential to receive development, regulatory and commercial milestone payments and double-digit royalties in the teens on tiers of annual net sales. The Mundipharma Collaboration Agreement requires, among other things, that we complete the rezafungin development program. On March 31, 2021, we entered into an exclusive, worldwide license and collaboration agreement, or the Janssen Collaboration Agreement, with Janssen Pharmaceuticals, Inc., or Janssen, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize our Cloudbreak drug-Fc conjugates, or DFCs, for the prevention and treatment of seasonal and pandemic influenza. Under the collaboration, we will be responsible for the development and manufacturing of the first influenza DFC, CD388, into the clinic and through Phase 2 clinical development, and Janssen will be responsible for late-stage development, manufacturing, registration and global commercialization. We received an upfront payment of $27.0 million. Janssen will fund all future research, development, manufacturing and commercialization for CD388, of which Janssen has funded $41.6 million as of September 30, 2023. On July 26, 2022, we entered into a License Agreement, or the Melinta License Agreement, with Melinta Therapeutics, LLC, or Melinta, pursuant to which we granted Melinta an exclusive license to develop, register and commercialize rezafungin in the U.S. in exchange for a $30.0 million upfront payment and the potential to receive regulatory and commercial milestone payments and tiered royalties on U.S. sales in the low double digits to mid-teens. The Melinta License Agreement requires, among other things, that we complete the rezafungin development program. Our ability to meet our development obligations under the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement depends on our ability to obtain additional funding.

There can be no assurance that additional funds will be available from any source or, if available, will be available on terms that are acceptable to us. There can also be no assurance that additional funds will be available to us without first obtaining the approval of our stockholders, which can be a difficult and lengthy process with an uncertain outcome.

Even if we raise additional capital, our expenses may increase in connection with our ongoing activities beyond what is currently expected. Our future capital requirements will depend on many factors, including:

•the costs and timing to complete our Phase 3 ReSPECT trial, the remaining Chinese portion of the ReSTORE trial and the CD388 Phase 1 and Phase 2a trials;

•the costs, timing and outcome of any regulatory review of rezafungin, CD388, CBO421 or future development candidates;

•our ability to establish and maintain collaborations, when and if necessary, on favorable terms, if at all;

•the costs and timing of commercialization activities, including manufacturing, marketing, sales and distribution, for rezafungin or any future product candidates that receive marketing approval;

•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

•the scope, progress, results and costs of drug discovery, preclinical development, manufacturing development, laboratory testing and clinical trials for our product candidates, for the Cloudbreak platform; and

•the extent to which we acquire or in-license other product candidates and technologies.

Identifying potential development candidates and conducting preclinical studies, manufacturing development and clinical trials are time consuming, expensive and uncertain processes that take years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales for any of our current or future product candidates. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.

Accordingly, we need substantial additional funding in connection with our continuing operations and to achieve our goals. As of September 30, 2023, we had cash and cash equivalents of $48.7 million.

The global credit and financial markets have recently experienced extreme volatility and disruptions, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. If the equity and credit markets continue to deteriorate, it may make any additional debt or equity financing more difficult, more costly and more dilutive. In addition, we may not be able to access a portion of our existing cash and cash equivalents due to market conditions. For example, the recent closures of Silicon Valley Bank, Signature Bank and First Republic Bank have resulted in broader financial institution liquidity risk and concerns. While we do not have deposits with these banks, if other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash and cash equivalents may be threatened, which could have a material adverse effect on our business and financial condition. In addition, if the financial market disruptions and economic slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could negatively affect our financial condition and our ability to pursue our business strategy.

If we are unable to raise additional capital on attractive terms or at all, we may be forced to delay, reduce or eliminate our development programs, including CD388, CBO421 or one or more of our other Cloudbreak DFC programs, be unable to continue the development of rezafungin, complete the ReSPECT Phase 3 clinical trial and meet our development obligations under the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement, or our other current and future license or collaboration agreements, and/or be forced to make reductions in spending, extend payment terms with suppliers, and/or liquidate or grant rights to assets where possible. Any of these actions could materially harm our business, results of operations and future prospects.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.*

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity, debt or other financing structures, receipt of payments under the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement, as well as potentially entering into other collaborations, strategic alliances or licensing arrangements with third parties or receiving government and/or charitable grants or contracts. In November 2018, we entered into a new controlled equity offering sales agreement with Cantor Fitzgerald & Co., or the Sales Agreement, which currently has an aggregate offering price of up to $50.0 million, and, other than the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement, it is our only current external source of potential financing.

In September 2019, we issued $9.0 million of our common stock to Mundipharma in connection with entering into the Mundipharma Collaboration Agreement. In February 2020, we issued $30.0 million of our common stock and Series X Convertible Preferred Stock upon the closing of a rights offering. In October 2021, we issued $38.5 million of our common stock and Series X Convertible Preferred Stock upon the closing of concurrent but separate public offerings. In March 2023, we issued shares of our common stock and Series X Convertible Preferred Stock upon the closing of concurrent but separate public offerings, for gross proceeds of $19.5 million. As of September 30, 2023, we have ~~been~~issued 20,769,854 shares of common stock pursuant to the Sales Agreement with an aggregate offering price of approximately $41.1 million. To the extent that we raise additional capital through the sale of equity or convertible debt securities, like the sale of our common stock to Mundipharma, the sale of our common stock and ~~could~~Series X Convertible Preferred Stock issued in our rights offering, the sale of our common stock and Series X Convertible Preferred Stock in our concurrent underwritten public offerings or the sale of common stock under the Sales Agreement, your ownership interest will be diluted and the

terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may be secured by all or a portion of our assets.

If we raise funds by entering into collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. On September 3, 2019, we licensed all rights to rezafungin outside of the U.S. and Japan to Mundipharma in exchange for certain payments and double-digit royalties in the teens on tiers of annual net sales. In March 2021, we granted exclusive worldwide rights to CD388 and other influenza DFCs to Janssen in exchange for certain payments and royalties on tiers of annual net sales at rates from the mid-single digits to the high-single digits. In July 2022, we licensed all rights to rezafungin inside of the U.S. to Melinta in exchange for certain payments and tiered royalties on U.S. sales in the low double digits to mid-teens. We may need to enter into similar agreements with other third parties for the development and commercialization of rezafungin outside of the Mundipharma and Melinta territories, or for the development of DFCs identified from our Cloudbreak program outside the scope of the Janssen Collaboration Agreement, which may require we relinquish valuable rights to these products.

If we raise funds through government grants and contracts, we may be subject to restrictions on our operations or certain unfavorable terms. U.S. government grants and contracts, if available, typically contain unfavorable termination provisions and are subject to audit and modification by the government at its sole discretion, which will subject us to additional risks. If we receive a U.S. government grant or contract, we would be required to comply with numerous laws and regulations relating to the formation, administration and performance of the grant or contract, which can make it more difficult for us to retain our rights under such grant or contract and result in increased costs.

If we are unable to raise additional funds through equity, debt or other financing structures, or through collaborations, strategic alliances or licensing arrangements with third parties, or through receiving government and/or charitable grants or contracts, we may be required to delay, reduce or terminate our rezafungin development program, including our ReSPECT Phase 3 clinical trial, be unable to meet our development obligations under the Mundipharma Collaboration Agreement and the Melinta License Agreement, and be unable to continue advancing the Cloudbreak program for non-influenza DFCs, or be forced to grant rights in the Cloudbreak program for non-influenza DFCs that we would otherwise prefer to retain for ourselves.

We have incurred significant operating losses since our inception, and we anticipate that we will continue to ~~be adversely impacted by~~incur substantial operating losses for the ~~current public health pandemic related to COVID-19.~~foreseeable future. We may never achieve or maintain profitability.*

In January 2020, the World Health Organization, or WHO, announced a global health emergency because of a new strain of novel coronavirus known as COVID-19 and, in March 2020, the WHO declared the COVID-19 outbreak a pandemic, or the COVID-19 pandemic. The COVID-19 pandemic has resulted in significant governmental measures being implemented to control the spread of the virus, including quarantines, travel restrictions and business interruptions and shutdowns. These precautions have disruptedSince our ~~business operations and prospects. For example,~~inception, we have ~~experienced,~~incurred significant operating losses. We had net loss of $17.3 million and $16.4 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, we had an accumulated deficit of $424.3 million. To date, we have financed our operations primarily through sale of our stock in public offerings and private placements, through borrowings under loan facilities, and through payments received in connection with the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement. We are currently conducting the ReSPECT and ReSTORE China Phase 3 clinical trials of rezafungin, Phase 1 and Phase 2a studies of CD388, and preclinical studies of our other DFCs, including CBO421. We expect to continue to ~~experience, trial site activation~~incur significant expenses and ~~enrollment delays~~increasing operating losses for the ~~ReSPECT~~foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially if and as we:

•submit investigational new drug applications, or INDs, to the U.S. Food and Drug Administration, or FDA, and equivalent filings to other regulatory authorities, and seek approval of our clinical protocols by institutional review boards at clinical trial ~~due~~sites;

•continue to ~~facility restrictions, quarantines, travel restrictions, focus on COVID-specific trials~~advance rezafungin and CD388 through clinical development;

•continue the preclinical development of our other DFCs from our Cloudbreak platform or otherwise, and advance one or more of such product candidates into clinical trials;

•seek marketing approvals for rezafungin, CD388, CBO421 and other ~~obstacles. Our NDA~~product candidates;

•establish or contract for ~~rezafungin may~~a sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtain marketing approval;

•maintain, expand and enforce our intellectual property portfolio;

•hire additional manufacturing, clinical, regulatory, quality assurance and scientific personnel;

•add operational, financial and management systems and personnel, including personnel to support product development; and

•acquire or in-license other product candidates and technologies.

To become and remain profitable, we must develop and eventually commercialize one or more products with significant market potential. This will require us to be ~~adversely impacted by the pandemic if FDA personnel are redirected to pandemic-related product reviews or if FDA personnel are unable to travel to conduct manufacturing or~~successful in a range of challenging activities, including completing preclinical studies and clinical ~~site inspections in conjunction with the review~~trials of our ~~NDA. The COVID-19 outbreak~~product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing and ~~mitigation measures also have had~~selling those product candidates for which we may obtain marketing approval, and satisfying any post-marketing requirements. We may ~~continue~~never succeed in these activities and, even if we do, may never generate revenue that is significant or large enough to ~~have an adverse impact on global economic conditions which~~achieve profitability. Our failure to become and remain profitable would decrease our value and could impair our ability to raise capital, ~~when needed. While the disruption from COVID-19 has had~~maintain our research and ~~we expect it to continue to have an adverse effect on~~development efforts, expand our business ~~financial condition and results~~or continue our operations. A decline in the value of ~~operations, we are unable~~our company could also cause you to ~~predict the extent~~lose all or ~~nature~~part of ~~these impacts at this time. In addition, to the extent the ongoing COVID-19 outbreak continues to~~your investment.

Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.*

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. The recent global financial crisis caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn, such as the recent global financial crisis, could result in a variety of risks to our business, including our ability to raise additional capital when needed on acceptable terms, if at all. This is particularly true in Europe, which is undergoing a continued severe economic crisis. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

The global credit and financial markets have recently experienced extreme volatility and disruptions, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, ~~prospects,~~rising inflation, bank failures, increases in unemployment rates and uncertainty about economic stability. If the equity and credit markets continue to deteriorate, it may make access to our liquidity within the U.S. banking system and any additional debt or equity financing more difficult, more costly and more dilutive.

The conflict between Russia and Ukraine could lead to disruption, instability and volatility in global markets and industries that could negatively impact our operations. The U.S. government and other governments in jurisdictions in which we operate have imposed severe sanctions and export controls against Russia and Russian interests and threatened additional sanctions and controls. The impact of these measures, as well as potential responses to them by Russia, is currently unknown and they could adversely affect our business, supply chain, partners or customers.

We have no history of commercializing pharmaceutical products, which may make it difficult for you to evaluate the prospect for our future viability.*

We have not yet demonstrated an ability to conduct sales and marketing activities necessary for successful commercialization. Typically, it takes many years to develop one new product from the time it is discovered to when it is commercially available. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history or if we had product candidates in advanced clinical trials.

In addition we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors that may alter or delay our plans. We will need to continue to transition from a company with a research focus to a company capable of supporting late-stage development activities and, if a product candidate is approved, a company with commercial activities. We may not be successful in any step of such a transition.

If we are unable to continue to satisfy the applicable continued listing requirements of Nasdaq, our common stock could be delisted.

Our common stock is currently listed on The Nasdaq Capital Market under the symbol “CDTX.” In order to maintain this listing, we must continue to satisfy minimum financial and other continued listing requirements and standards. We cannot assure you that we will be able to continue to comply with the applicable listing standards.

If we are not able to comply with applicable listing standards, our shares of common stock will be subject to delisting. For example, we were first notified by Nasdaq on February 28, 2022, that our common stock had failed to maintain a minimum bid price of $1.00 for 30 consecutive business days. Following extension periods to regain compliance, On February 9, 2023, the Nasdaq Hearings Panel notified us that we had regained compliance with the minimum bid price requirement subject to a discretionary Panel Monitor until November 9, 2023. The delisting of our common stock from trading on Nasdaq may have a material adverse effect on the market for, and liquidity and price of, our common stock and impair our ability to raise capital. Delisting from Nasdaq could also have other negative results, including, without limitation, the ~~effect~~potential loss of ~~heightening many~~confidence by customers and employees, the loss of institutional investor interest and fewer business development opportunities. In the ~~other risks~~event that our common stock is delisted from Nasdaq and ~~uncertainties described elsewhere~~is not eligible for quotation or

listing on another market or exchange, trading of our common stock could be conducted only in ~~this "Risk Factors" section.~~the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further.

Risks Related to Drug Discovery, Development and Commercialization

We depend heavily on the success of rezafungin ~~for~~and CD388, which ~~an NDA has been submitted to the FDA, and CD388,~~is currently in Phase 1 and Phase 2a clinical development, and we are very early in our efforts to develop other product candidates from our Cloudbreak program, none of which may be successful.*

We are currently conducting two Phase 3 clinical trials of rezafungin. We have completed the ReSTORE trial and conducted the primary analyses required for ~~potential~~ approval in U.S. and Europe but are continuing to enroll and treat patients in China to support Chinese regulatory filings. We also continue to enroll patients in the ReSPECT trial, which is designed to assess the safety and efficacy of rezafungin for the prevention of serious fungal infections in patients undergoing blood and marrow transplants. The ~~U.S. Food and Drug Administration, or~~ FDA ~~accepted for filing and granted Priority Review to~~approved our ~~New Drug Application,~~new drug application, or NDA, for rezafungin for the treatment of candidemia and invasive candidiasis in ~~September 2022. The FDA is planning to hold an advisory committee meeting to discuss the application.~~adults with limited or no treatment options, in March 2023. Even though ~~the NDA~~rezafungin has been ~~accepted~~approved for ~~filing,~~the treatment indication, we may ~~receive~~not be successful in obtaining approval for a ~~Complete Response Letter rather than approval, including~~supplemental NDA, or sNDA, for ~~reasons that~~the expanded prophylaxis indication. In addition, the European Medicines Agency, or EMA, may ~~be identified during a meeting of the advisory committee. Additionally, the FDA may issue a Complete Response Letter if it does~~ not ~~agree that the clinical benefits outweigh the risks or if~~approve rezafungin for any ~~of our clinical or manufacturing sites are found to be out of compliance with FDA requirements.~~

indication. The ReSPECT trial is currently enrolling globally.

We received IND clearance for CD388, our DFC for prevention and treatment of influenza, from the FDA in March 2022 and subsequently initiated a Phase 1 clinical trial. In September 2022, we initiated a Phase 2a trial of CD388 to evaluate the pre-exposure prophylactic activity of CD388 against influenza virus and a separate Phase 1 Japanese bridging study has been initiated. We are also conducting in vitro and in vivo preclinical studies of other product candidates from our Cloudbreak program for viral infections and oncology indications. Our assumptions about why rezafungin and CD388 are worthy of continued development, as well as our assumptions about the markets for rezafungin, CD388, CBO421 or any other potential products from our Cloudbreak program, are based on data primarily collected by other companies. The timing and costs of our preclinical and clinical development programs, the

likelihood of European marketing approval for rezafungin and any marketing approval for CD388, and the regulatory paths for marketing approval for additional products from our Cloudbreak program remain uncertain. Our ability to generate product revenue, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our product candidates. The success of rezafungin, CD388, CBO421 and any other product candidates we may develop will depend on many factors, including the following:

•~~the impact of the COVID-19 pandemic on our operations;~~

•our ability to secure adequate additional funding;

•agreement with regulatory authorities on study designs and other requirements for study initiation;

•successful completion of preclinical studies;

•successful enrollment and completion of clinical trials;

•demonstration of safety and efficacy;

•receipt of marketing approvals from applicable regulatory authorities;

•negotiation of favorable indications and other key elements of the product labeling;

•establishing clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers;

•obtaining and maintaining patent and trade secret protection and non-patent exclusivity for our product candidates and technologies;

•launching commercial sales of the product candidates if and when approved;

•acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors;

•effectively competing with other therapies;

•a continued acceptable safety profile of the products following approval; and

•enforcing and defending intellectual property rights and claims.

If we do not timely enroll the ReSPECT Phase 3 clinical trial, or if we are unable to secure significant additional funding, we will not be able to complete the clinical development plans for the prophylaxis indication for rezafungin. If we do not

accomplish one or more of any of the other goals in a timely manner, or at all, we could experience significant delays or an inability to successfully complete the development of and commercialize our product candidates, which would harm our business.

If we experience delays or difficulties in enrolling patients in our clinical trials our receipt of necessary regulatory approvals could be delayed or prevented.*

We may not be able to complete the ReSPECT clinical trial or the ongoing portion of the ReSTORE trial in China if we are unable to identify and enroll a sufficient number of eligible patients, as required by the FDA or similar regulatory authorities outside the U.S., or if we do not believe that the number of patients required by such regulatory authorities can be enrolled in a reasonable timeframe.

Our rezafungin Phase 3 clinical development program is a global program and, as such, our ability to timely enroll the clinical trials may be affected by many different factors specific to those global localities, such as, delays in our receipt of approval to commence trials in a particular country from applicable regulatory authorities and ethics committees, timely completion of clinical trial site initiation within each country, delays in local importation and receipt of necessary clinical trial supplies, and our ongoing compliance with local regulations, which may change during the course of the clinical trial.

In addition, the rezafungin clinical trials are heavily reliant on third-party contractors, including contractors that import clinical trial materials, and contract research organizations, or CROs, that conduct and monitor our clinical trials, and interact with regional or local regulators and ethics committees on our behalf. If we experience significant difficulties with any of our key contractors such that we determine it is in the best interests of the clinical trials to replace a key contractor, this could result in a significant delay in enrollment.

~~Additionally, timely enrollment in the ReSPECT trial is reliant on global clinical trial sites, most of which have been adversely affected by the COVID-19 global pandemic. For example, the~~The COVID-19 global pandemic has significantly impacted our ability to activate sites and enroll patients in the ReSPECT trial in ~~Europe~~the European Union, or EU, Canada and the U.S., resulting in substantial delays and increases in the cost of completing the trial. Our enrollment of patients in ReSTORE in China was

also delayed in part due to the pandemic. ~~Some factors from the COVID-19 coronavirus outbreak that have adversely affected enrollment in our Phase 3 trials include:~~

•the diversion of healthcare resources away from the conduct of clinical trial matters to focus on pandemic concerns, including the attention of infectious disease physicians serving as our clinical trial investigators, hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

•~~the decision of some clinical trial sites to focus on the conduct of COVID-19 clinical trials;~~

•~~limitations imposed by hospitals serving as our clinical trial sites that prohibit entry on hospital premises by persons other than those supporting the hospital's COVID-19 efforts;~~

•~~limitations on travel that interrupt key trial activities, such as clinical trial site initiations and monitoring;~~

•~~interruption in global shipping affecting the transport of clinical trial materials, such as investigational drug product and comparator drugs used in our trials; and~~

•~~employee quarantine or isolation days that delay necessary interactions with local regulators, ethics committees and other important agencies and contractors.~~

These and other factors arising from the COVID-19 coronavirus could worsen in countries that are already afflicted with the virus or could continue to spread to additional countries, each of which may further adversely impact our Phase 3 trials. The global outbreak of the COVID-19 coronavirus continues to evolve and the conduct of our Phase 3 trials may continue to be adversely affected, despite efforts to mitigate this impact.

In addition, some of our competitors may have ongoing or new clinical trials for product candidates that would treat the same indications as rezafungin, or be used in the same patients and, therefore, patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates. Patient enrollment may also be affected by other factors, including:

•eligibility criteria, including regional or local practices that place additional limitations on patient eligibility;

•availability, safety and efficacy of approved medications or other investigational medications being studied clinically for the disease under investigation;

•perceived risks and benefits of rezafungin;

•efforts to facilitate timely enrollment in clinical trials;

•reluctance of physicians to encourage patient participation in clinical trials;

•the ability to monitor patients adequately during and after treatment;

•the proximity and availability of clinical trial sites for prospective patients;

•delays or failures in maintaining an adequate supply of quality drug product for use in clinical trials; and

•changing treatment patterns that may reduce the burden of disease which ~~rezfungin~~rezafungin addresses.

Our inability to enroll and retain a sufficient number of patients in a reasonable timeframe may require us to abandon the entire rezafungin Phase 3 clinical development program or terminate the ReSPECT trial or the ReSTORE trial in China. Enrollment delays have and will continue to result in increased development costs, which could cause the value of our company to decline and could limit our ability to obtain necessary additional financing. For example, in the ReSPECT trial, a blinded interim analysis is planned in the first quarter of 2024 which will inform the current fungal free survival rates, or FFS. The FFS will determine if the 462 patients planned to be enrolled will be sufficient to power the trial to maintain non-inferiority. If the number of patients planned to be enrolled are not sufficient, the trial may need to enroll more patients which may potentially impact the overall timing to top-line data and increase trial costs. The study is currently enrolling in the EU, Canada and the U.S.

If clinical trials for rezafungin, CD388, CBO421 or any other product candidates are delayed, terminated or suspended, or fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, we may incur additional costs, or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.*

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A delay in starting or completing our clinical trials would materially impact our timelines and our ability to complete development of our product candidates in a timely manner or at all. For example, our entire rezafungin clinical development program has been severely impacted by the effects of ~~the COVID-19 global pandemic.~~COVID-19. Additionally, our ability to complete our rezafungin Phase 3 development program is dependent on our ability to secure adequate additional funding.

A failure of one or more clinical trials could occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a particular clinical trial do not necessarily predict final results of that trial.

Moreover, preclinical and clinical data are often susceptible to multiple interpretations and analyses. Many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products. For example, the historically observed high rate of correlation for clinical efficacy for anti-infectives based on preclinical data may not apply for our current or future product candidates, and any of the potential benefits that we anticipate for human clinical use may not be realized.

We do not know whether either the ReSPECT trial or the Phase 1 or Phase 2a trials of CD388 will be completed on schedule. We ~~have experienced significant delays in these trials arising from the COVID-19 global pandemic. We~~ may experience numerous ~~other~~ unforeseen events that could delay or prevent our ability to commence or complete our clinical trials, which could then delay or prevent our ability to receive marketing approval or commercialize our product candidates, including:

•regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial on our expected timeline, or at all, or conduct a clinical trial at a prospective trial site or in a given country;

•regulators may disagree with our interpretation of preclinical data, which may impact our ability to commence our trials on our expected timeline or at all;

•regulators may require that trials or studies be conducted, or sized or otherwise designed in ways, that were unforeseen in order to begin planned studies or to obtain marketing authorization;

•we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

•clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials, modify planned clinical trial designs or abandon product development programs;

•the number of patients required for clinical trials of our product candidates may be larger than we anticipate;

•enrollment in these clinical trials may be slower than we anticipate, clinical sites may drop out of our clinical trials or participants may drop out of these clinical trials at a higher rate than we anticipate;

•our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

•regulators, institutional review boards or the data safety monitoring board assembled by us to oversee our rezafungin clinical trials may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks due to serious and unexpected side effects;

•the cost of clinical trials of our product candidates may be greater than we anticipate;

•the FDA or comparable foreign regulatory authorities could require that we perform more studies than, or evaluate clinical endpoints other than, those that we currently expect;

•the supply of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be delayed or insufficient, or the quality of such materials may be inadequate; and

•we may be required to delay or terminate studies due to financial constraints.

If the FDA or similar regulatory authorities outside the U.S. do not agree with the design and implementation of our planned or ongoing clinical trials, including the safety database to support an NDA submission, or if we are unable to secure additional funding, we may not be able to complete the overall Phase 3 clinical development program for

rezafungin as currently envisioned. If we do not accomplish one or more of any of the other goals in a timely manner, or at all, we could experience significant delays or an inability to successfully complete the development of and commercialize our product candidates, which would harm our business. If we are required to conduct additional clinical trials, or other tests of our product candidates beyond those that we currently contemplate, if we are unable to complete clinical trials of our product candidates or other tests successfully or in a timely manner, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:

•be delayed in obtaining marketing approval for our product candidates;

•not obtain marketing approval at all;

•obtain approval for indications or patient populations that are not as broad as intended or desired;

•obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

•be subject to additional post-marketing testing requirements;

•be subject to significant restrictions on reimbursement from public and/or private payors; or

•have the product removed from the market after obtaining marketing approval.

Product development costs will also increase if we experience delays in testing or in receiving marketing approvals. We do not know whether any clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates, could allow our competitors to bring products to market before we do, could increase competition from generics of the same class, and could impair our ability to successfully commercialize our product candidates, any of which may harm our business and results of operations.

If serious adverse reactions or unexpected characteristics of our product candidates are identified during development, we may need to abandon or limit our development of some or all of our product candidates.

Because it is impossible to predict when or if any of our product candidates will prove effective or safe in humans or will receive marketing approval, the risk of each of our programs is high. If our product candidates are associated with undesirable side effects or have characteristics that are unexpected, we may need to abandon their development or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. For example, the PKpharmacokinetic properties, such as a longer half-life or less frequent dosing regimen, that differentiate rezafungin from other echinocandins could have side effects that we have not anticipated and the consequences of such side effects could be more severe than have been seen with other echinocandins that have shorter half-lives or more frequent dosing regimens, or are dosed at lower concentrations than we expect for rezafungin.

Further, the treatment advantages that we are predicting for rezafungin, such as lower healthcare costs resulting from an ability to administer rezafungin once-weekly, which could allow earlier hospital discharge, or the predicted ability of rezafungin to be effective against resistant strains of fungal pathogens, may not be realized. For our DFCs, the bispecific mechanism of action, including the use of the immune system, may lead to side effects that are not anticipated based on the preclinical work we have conducted to date.

In the biotechnology industry, many agents that initially show promise in early stage testing may later be found to cause side effects that prevent further development of the agents. In addition, infections can occur in patients with co-morbidities and weakened immune systems, and there may be adverse events and deaths in our clinical trials that are attributable to factors other than investigational use of our product candidates.

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.*

We have limited financial resources. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential than opportunities we pursue. For example, we believe that ~~a supplemental NDA, or~~an sNDA filing for rezafungin adding the prophylaxis indication can be supported by one Phase 3 trial in prophylaxis, however, financial constraints may require us to delay our prophylaxis program.

In support of the global effort to identify effective therapeutics to treat and prevent the COVID-19 coronavirus ~~and stem the current global pandemic,~~ we have expended financial resources to identify DFCs which may be effective in this area. In addition, we have recently expended financial resources on identification of DFCs targeting multiple potentially synergistic oncology targets. We have limited experience in identification and nonclinical and clinical testing of oncology therapeutics. Our resource allocation decisions may not result in us identifying valuable products or may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the

commercial potential or target markets for a particular product candidate or opportunity, we may relinquish valuable rights to that product candidate or opportunity through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or opportunity.

~~Even if any~~Any of our product candidates that receive marketing approval ~~they~~ may fail to achieve the degree of market acceptance by physicians, patients, formulary committees, third-party payors and others in the medical community necessary for commercial success.*

~~If any~~Any of our product candidates that receive marketing approval ~~they~~ may nonetheless fail to gain sufficient market acceptance by hospitals and hospital pharmacies, physicians, patients, third-party payors and others in the medical community for us to achieve commercial success. If our product candidates do not achieve an adequate level of acceptance, we may not generate sufficient product revenue to become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

•the efficacy and potential advantages compared to alternative therapies;

•the size of the markets in the countries in which approvals are obtained;

•terms, limitations or warnings contained in any labeling approved by the FDA or other regulatory authority;

•our ability to offer any approved products for sale at competitive prices;

•convenience and ease of administration compared to alternative treatments;

•the willingness of the target patient population to try new therapies or dosing regimens;

•the willingness of physicians to prescribe these therapies and, in the case of rezafungin, transition to a once-weekly dosing regimen from traditional once-daily dosing;

•the strength of marketing and distribution support;

•the success of competing products and the marketing efforts of our competitors;

•sufficient third-party payor coverage and adequate reimbursement; and

•the prevalence and severity of any side effects.

If, in the future, we are unable to establish sales and marketing capabilities or to selectively enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing our product candidates, if and when they are approved. In addition, if we enter into agreements with third parties to sell and market our product candidates, such third parties may not be successful in commercializing our products.*

We do not have a sales or marketing infrastructure. To achieve commercial success for any approved product, we must license the rights to third parties with such capabilities, develop a sales and marketing organization or outsource these functions to third parties.

There are risks involved both with establishing our own sales and marketing capabilities and with entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly and our investment would be lost if we cannot reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our product candidates on our own include:

•our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

•the inability of sales personnel to obtain access to physicians or to achieve adequate numbers of prescriptions for any future products; and

•costs and expenses associated with creating an independent sales and marketing organization.

If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenue or the profitability of these product revenues to us may be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that are favorable to us. We may have little control over such third parties and any of them may fail to market and sell our products effectively, including by failing to devote

the necessary resources and attention. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.

If we do establish relationships with third parties to sell and market our product candidates, such third parties may not be successful in commercializing those products. For example, in the U.S. we are entirely dependent on Melinta to commercialize rezafungin. Melinta has no experience with commercialization of antifungal drugs and may be unable to hire individuals with the requisite expertise or develop and execute an appropriate commercialization plan.

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.*

The development and commercialization of new drug products is highly competitive. We face competition with respect to our current product candidates, and will face competition with respect to any product candidates that we may seek to

develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Regulatory incentives to develop drugs for treatment of infectious diseases have increased interest and activity in this area and will lead to increased competition for clinical investigators and clinical trial subjects, as well as for future prescriptions, if any of our product candidates are successfully developed and approved. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the indications on which we are focusing our product development efforts. Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to our approach and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

We expect that rezafungin will primarily compete with certain antifungal classes of drugs, which include polyenes, azoles and echinocandins. Approved branded echinocandin antifungal therapies include Cancidas (caspofungin, marketed by Merck & Co.), Eraxis (anidulafungin, marketed by Pfizer, Inc.), and Mycamine (micafungin, marketed by Astellas Pharma US, Inc.). We expect that there will be generics of all of the current echinocandins available at the time of rezafungin market approval, which will create added competition. In addition, there are other generic products approved for candidemia, marketed by companies such as Baxter Healthcare Corporation, Mylan Inc. and Glenmark Generics Inc., among others. In addition to approved therapies, we expect that rezafungin will compete with product candidates that we are aware of in clinical development by third parties, such as ~~SCY-078,~~fosmanogepix (PF-07842805), which is being developed by Pfizer, Inc. and brexafungerp, which is approved for other indications and is being developed for invasive candidiasis by Scynexis, Inc.

We expect that ~~if we are successful in developing influenza product candidates identified through our Cloudbreak program, such product candidates~~CD388 will compete against approved and investigational agents for the treatment or prevention of viral influenza infections, including influenza vaccines, neuraminidase inhibitors such as Tamiflu, Relenza and Peramivir, and endonuclease inhibitors such as Xofluza. We may develop other product candidates through our Cloudbreak platform for the treatment or prevention of other serious diseases, such as ~~the SARS-CoV-2 strains causing COVID-19,~~RSV, HIV and various cancers. We are aware of a large number of approved and investigational therapies in these areas also. We expect that CBO421 will compete against approved anticancer therapeutics as well as investigational CD-73 targeting small molecule drugs, including Oric-533 being developed by Oric Pharmaceutical, Inc. and quemliclustat being developed by Arcus Biosciences, Inc. as well as monoclonal antibodies, including oleclumab being developed by AstraZeneca PLC.

Our competitors may develop products that are more effective, safer, more convenient or less costly than any that we are developing or that would render our product candidates obsolete or non-competitive. Our competitors may also obtain marketing approval from the FDA or other regulatory authorities for their products sooner than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Many of our competitors have significantly greater name recognition, financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These same competitors may invent technology that competes with our rezafungin program, CD388, CBO421, or our Cloudbreak platform.

These third parties may compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient enrollment for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we ~~may~~ publicly disclose interim, preliminary or topline data from our clinical studies, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analysis of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our clinical studies. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

Further, others, including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, drug candidate or our business. If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

Even if we are able to commercialize any product candidates, these products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drugs vary widely from country to country. In the U.S., new and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product-licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial marketing approval is granted. As a result, we might obtain marketing approval for a drug in a particular country but then be subject to price regulations that delay its commercial launch, possibly for lengthy time periods, and negatively impact the revenue we are able to generate from the sale of the drug in that country. Adverse pricing limitations may hinder our ability to commercialize and generate revenue from one or more product candidates, even if our product candidates obtain marketing approval.

Our ability to commercialize any product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health programs, private health insurers, integrated delivery networks and other third-party payors. Third-party payors decide which medications they will pay for and establish reimbursement levels. A significant trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of payment for particular medications. Increasingly, third-party payors are requiring that drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage and reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement may not be sufficient for commercial success. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing approval.

There may be significant delays in obtaining coverage and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved by the FDA or similar regulatory authorities outside the U.S. Moreover, eligibility for coverage and reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be

made permanent. Coverage and reimbursement rates may vary according to the use of the drug and the medical circumstances under which it is used may be based on reimbursement levels already set for lower cost products or procedures or may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the U.S. Commercial third-party payors often rely upon Medicare coverage policies and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded programs and private payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize our approved products and our overall financial condition. Further, coverage policies and third-party payor reimbursement rates may change at any time. Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future.

Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the commercialization of any product candidates we may develop.*

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and we ~~will~~ face an even greater risk ~~if we commercially sell any~~for our products that receive marketing approval. If we cannot successfully defend ourselves against claims that our product candidates and products caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

•decreased demand for any product candidates that we may develop;

•injury to our reputation and significant negative media attention;

•withdrawal of clinical trial participants;

•significant costs and distraction of management to defend any related litigation;

•the initiation of investigations by regulatory bodies;

•substantial monetary awards to trial participants or patients;

•loss of revenue;

•product recalls, withdrawals or labeling, marketing or promotional restrictions; and

•the inability to commercialize any products we may develop.

Although we have product liability insurance for our clinical trials, such insurance may not be adequate to cover all liabilities that we may incur. We anticipate that we will need to increase our insurance coverage as we continue or expand our clinical trials and if we successfully commercialize any products. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees in our workplace, including those resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, chemical, hazardous or radioactive materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

We may not be successful in our efforts to identify, discover, and develop potential product candidates through our Cloudbreak platform or otherwise.*

Through our Cloudbreak platform, we are developing DFCs for the treatment and prevention of serious diseases, including influenza ~~the SARS-CoV-2 strains causing COVID-19,~~ and various cancers. We have nominated the DFC CD388 as our lead development candidate for ~~influenza.~~influenza, and we have nominated CBO421 as our lead oncology DFC candidate. In applying our Cloudbreak platform, we may not be successful in identifying additional DFCs that could be developed as drug therapies. In addition, our Cloudbreak platform may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for a number of reasons. In particular, our research methodology used may not be successful in identifying compounds with sufficient potency, bioavailability or efficacy to be potential product candidates. In addition, our potential product candidates may, on further study, be shown to have harmful side effects or other negative characteristics.

Research programs to identify new product candidates require substantial technical expertise and human resources. For example, we have limited experience with the use of the Cloudbreak platform applied to viral pathogens and oncology

targets. A failure to optimize our expertise using the Cloudbreak platform for the development of our Cloudbreak program may limit our ability to successfully advance this program and identify future product candidates. Research programs to identify new product candidates also require substantial financial resources. We may choose to expend our financial resources on potential product candidates that ultimately prove to be unsuccessful. For example, ~~in response to the immediate global pandemic crisis,~~ we have expended financial resources to identify therapeutics to treat or prevent the COVID-19 coronavirus, and we may be unsuccessful in identifying such a DFC. If we are unable to identify successful product candidates from our Cloudbreak platform for preclinical and clinical development, we will have spent financial resources on programs that did not yield viable products and therefore generate product revenue, which would harm our financial position and adversely impact our stock price.

~~Risks Related to Our Financial Position and Need for Additional Capital~~

We need substantial additional funding to complete the development of rezafungin and to advance CD388 and our Cloudbreak program.*

In connection with the preparation of our financial statements for the period ended September 30, 2022, we performed an analysis of our ability to continue as a going concern. We believe, based on our current business plan, that our existing cash and cash equivalents will not be sufficient to fund our obligations for the next twelve months. Our ability to continue to fund the development of rezafungin through completion of our planned Phase 3 trials depends on our ability to obtain additional funding. Our ability to advance CD388 and other product candidates from our Cloudbreak program is also dependent on our ability to obtain additional funding.

On September 3, 2019, we entered into the Mundipharma Collaboration Agreement, pursuant to which we granted Mundipharma exclusive commercialization rights to rezafungin outside the U.S. and Japan in exchange for a $30.0 million upfront payment, near-term funding to support the global Phase 3 ReSTORE and ReSPECT trials, and the potential to receive development, regulatory and commercial milestone payments and double-digit royalties in the teens on tiers of annual net sales. The Mundipharma Collaboration Agreement requires, among other things, that we complete the rezafungin development program. On March 31, 2021, we entered into the Janssen Collaboration Agreement, to develop and commercialize our Cloudbreak DFCs for the prevention and treatment of seasonal and pandemic influenza. Under the collaboration, we will be responsible for the development and manufacturing of the first influenza DFC, CD388, into the clinic and through Phase 2 clinical development, and Janssen will be responsible for late-stage development, manufacturing, registration and global commercialization. We received an upfront payment of $27.0 million. Janssen will fund all future research, development, manufacturing and commercialization for CD388, of which Janssen has funded $20.6 million as of September 30, 2022. On July 26, 2022, we entered into the Melinta License Agreement, pursuant to which we granted Melinta an exclusive license to develop, register and commercialize rezafungin in the U.S. in exchange for a $30.0 million upfront payment and the potential to receive regulatory and commercial milestone payments and tiered royalties on U.S. sales in the low double digits to mid-teens. The Melinta License Agreement requires, among other things, that we complete the rezafungin development program. Our ability to meet our development obligations under the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement depends on our ability to obtain additional funding.

•~~the ongoing effect of the COVID-19 global pandemic and the resulting impact on our rezafungin phase 3 clinical development program;~~

•~~the costs and timing to complete our Phase 3 ReSPECT trial, the remaining Chinese portion of the ReSTORE trial and the CD388 Phase 1 and Phase 2a trials;~~

•~~the costs, timing and outcome of any regulatory review of rezafungin, CD388 or future development candidates;~~

•~~our ability to establish and maintain collaborations, when and if necessary, on favorable terms, if at all;~~

•~~the costs and timing of commercialization activities, including manufacturing, marketing, sales and distribution, for rezafungin or any future product candidates that receive marketing approval;~~

•~~the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;~~

•~~the extent to which we acquire or in-license other product candidates and technologies.~~

~~Accordingly, we need substantial additional funding in connection with our continuing operations and to achieve our goals. As of September 30, 2022, we had cash and cash equivalents of $53.1 million.~~

As a result of the COVID-19 pandemic and actions taken to slow its spread, the global credit and financial markets have recently experienced extreme volatility and disruptions, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. If the equity and credit markets continue to deteriorate, it may make any additional debt or equity financing more difficult, more costly and more dilutive.

If we are unable to raise additional capital on attractive terms or at all, we may be forced to delay, reduce or eliminate our development programs, including CD388 or one or more of our other Cloudbreak DFC programs, be unable to continue the development of rezafungin, complete the ReSPECT Phase 3 clinical trial and meet our development obligations under the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement, or our other current and future license or collaboration agreements, and/or be forced to make reductions in spending, extend payment terms with suppliers, and/or liquidate or grant rights to assets where possible. Any of these actions could materially harm our business, results of operations and future prospects.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.*

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity, debt or other financing structures, receipt of payments under the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement, as well as potentially entering into other collaborations, strategic alliances or licensing arrangements with third parties or receiving government and/or charitable grants or contracts. In November 2018, we entered into the Sales Agreement which currently has an aggregate offering price of up to $50.0 million, and, other than the Mundipharma Collaboration Agreement, the Janssen Collaboration Agreement and the Melinta License Agreement, it is our only current external source of potential financing.

In September 2019, we issued $9.0 million of our common stock to Mundipharma in connection with entering into the Mundipharma Collaboration Agreement. In February 2020, we issued $30.0 million of our common stock and Series X Preferred Stock upon the closing of a rights offering. In October 2021, we issued $38.5 million of our common stock and Series X Preferred Stock upon the closing of concurrent but separate public offerings. As of September 30, 2022, we have issued 13,443,622 shares of common stock pursuant to the Sales Agreement with an aggregate offering price of approximately $31.5 million. To the extent that we raise additional capital through the sale of equity or convertible debt securities, like the sale of our common stock to Mundipharma, the sale of our common stock and Series X Preferred Stock issued in our rights offering, the sale of our common stock and Series X Preferred Stock in our concurrent public offerings or the sale of common stock under the Sales Agreement, your ownership interest will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may be secured by all or a portion of our assets.

We have incurred significant operating losses since our inception, and we anticipate that we will continue to incur substantial operating losses for the foreseeable future. We may never achieve or maintain profitability.*

Since our inception, we have incurred significant operating losses. Our net losses were $16.4 million and $25.7 million for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022, we had an accumulated deficit of $393.6 million. To date, we have financed our operations primarily through sale of our stock in public offerings and private placements, through borrowings under loan facilities, and through payments received in connection with the Mundipharma Collaboration Agreement, Janssen Collaboration Agreement and Melinta License Agreement. We have devoted substantially all of our financial resources and efforts to research and development. We are currently conducting the ReSPECT and ReSTORE China Phase 3 clinical trials of rezafungin, Phase 1 and Phase 2a studies of CD388, and preclinical studies of our other DFCs. We expect that it will be many years, if ever, before we receive regulatory approval and have a product candidate available for commercialization. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially if and as we:

•~~submit INDs to the FDA and equivalent filings to other regulatory authorities, and seek approval of our clinical protocols by institutional review boards at clinical trial sites;~~

•~~continue to advance rezafungin and CD388 through clinical development;~~

•~~continue the preclinical development of our other DFCs from our Cloudbreak platform or otherwise, and advance one or more of such product candidates into clinical trials;~~

•~~seek marketing approvals for rezafungin, CD388 and other product candidates;~~

•~~establish or contract for a sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtain marketing approval;~~

•~~maintain, expand and enforce our intellectual property portfolio;~~

•~~hire additional manufacturing, clinical, regulatory, quality assurance and scientific personnel;~~

•~~add operational, financial and management systems and personnel, including personnel to support product development; and~~

•~~acquire or in-license other product candidates and technologies.~~

To become and remain profitable, we must develop and eventually commercialize one or more products with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing and selling those product candidates for which we may obtain marketing approval, and satisfying any post-marketing requirements. We may never succeed in these activities and, even if we do, may never generate revenue that is significant or large enough to achieve profitability. Our failure to become and remain profitable would decrease our value and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.*

Further, as a result of the COVID-19 pandemic and actions taken to slow its spread, the global credit and financial markets have recently experienced extreme volatility and disruptions, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, rising inflation, increases in unemployment rates and uncertainty about economic stability. If the equity and credit markets continue to deteriorate, it may make any additional debt or equity financing more difficult, more costly and more dilutive.

~~Our limited operating history may make it difficult for you to evaluate the success of our business to date and assess our future viability.~~

We were founded in December 2012 and our operations to date have been limited to organizing and staffing our company, business planning, raising capital, developing our technology, identifying potential development and product candidates, undertaking preclinical studies and conducting clinical trials. We have not yet demonstrated an ability to successfully complete large-scale, pivotal clinical trials required for regulatory approval of our product candidates, obtain marketing approvals, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. Typically, it takes many years to develop one new product from the time it is discovered to when it is commercially available. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history or if we had product candidates in advanced clinical trials.

~~If we are unable to continue to satisfy the applicable continued listing requirements of Nasdaq, our common stock could be delisted.~~

If we are not able to comply with applicable listing standards, our shares of common stock will be subject to delisting. The delisting of our common stock from trading on Nasdaq may have a material adverse effect on the market for, and liquidity and price of, our common stock and impair our ability to raise capital. Delisting from Nasdaq could also have other negative results, including, without limitation, the potential loss of confidence by customers and employees, the loss of institutional investor interest and fewer business development opportunities. In the event that our common stock is delisted from Nasdaq and is not eligible for quotation or listing on another market or exchange, trading of our common stock could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further.

Risks Related to Our Dependence on Third Parties

We are dependent on our collaboration partners to provide funding to continue the development of rezafungin and CD388; for the commercialization of rezafungin outside Japan; and for the late-stage development, manufacturing, registration and commercialization of CD388. If the collaborations are not successful, we may not be able to complete the development of rezafungin and CD388, or capitalize on the full market potential for rezafungin and CD388.*

On September 3, 2019, we licensed the rights to rezafungin outside of the U.S. and Japan to Mundipharma, a large international pharmaceutical company, and on July 26, 2022, we licensed the rights to rezafungin inside the U.S. to Melinta. Our ability to complete the development of rezafungin is dependent, in part, on funds provided by Mundipharma and Melinta. Additionally, our ability to receive payments from these arrangements will depend on Mundipharma’s and ~~Melinta's~~Melinta’s ability to successfully commercialize rezafungin in their respective territories.

The Mundipharma Collaboration Agreement and the Melinta License Agreement pose many risks to us, including that our collaborator, Mundipharma, and our licensee, Melinta:

•have significant discretion in determining the efforts and resources they will apply to commercializing rezafungin in their respective territories, and may not commit sufficient resources to the marketing and distribution of rezafungin;

•may be unable to successfully commercialize rezafungin in one or more territories because, following regulatory approval, they may be unable to obtain formulary pricing approval, reimbursement approval, and/or formulary placement;

•have limited experience commercializing antifungal therapeutics and therefore may be unsuccessful in developing and implementing commercial launch plans for rezafungin;

•may terminate the Mundipharma Collaboration Agreement at will and may terminate the Melinta License Agreement at will after July 26, 2023;

•may be subject to changes in key personnel or strategic focus, have limited available funding or be subject to other external factors diverting resources or creates competing priorities, all of which could negatively impact the commercialization of rezafungin in their respective territories;

•may independently develop, or develop with third parties, products that compete directly or indirectly with rezafungin if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

•may use our intellectual property or proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or proprietary information or expose us to potential litigation;

•may not agree with certain development decisions resulting in the delay or termination of the programs, or that result in costly litigation or arbitration that diverts management attention and resources;

•could be involved in a business combination and the continued pursuit and emphasis on rezafungin could be delayed, diminished or terminated; and

•could be financially impacted by ~~the COVID-19 pandemic.~~inflation or bank failures.

If our ability to generate revenue under the Mundipharma Collaboration Agreement and the Melinta License Agreement is adversely impacted by these or any other risks, our right to receive additional payments from the Mundipharma Collaboration Agreement and the Melinta License Agreement, including our share of the revenues generated by net sales of rezafungin, if approved, could be insufficient to allow us to complete our rezafungin development program including the ReSPECT Phase 3 clinical trial, to achieve or maintain profitability or may result in rezafungin being less valuable to us than if we had not entered into the Mundipharma Collaboration Agreement and the Melinta License Agreement.

On March 31, 2021, we licensed the exclusive worldwide rights to CD388 and other influenza DFCs to Janssen. Our ability to complete the development of CD388 is dependent, on funds provided by Janssen. As part of a recent prioritization of its R&D business, in July 2023 Janssen disclosed its intention to discontinue internal development of multiple product candidates in its infectious disease pipeline, including CD388. However, in September 2023 Janssen delivered its Election to Proceed Notice for CD388 whereby Janssen will assume the future development, manufacturing and commercialization activities of CD388 but intends to transfer its rights and obligations under the Janssen Collaboration Agreement to another transferee.

Following Janssen’s Election to Proceed Notice, Janssen, or any third-party transferee, is obligated at its sole expense to diligently continue development and commercialization either itself or through the transferee to whom it sublicenses or assigns the rights. If Janssen sublicenses or assigns the rights to a third party, then all terms under the current Janssen Collaboration Agreement will survive without modification. However, there is no guarantee that Janssen will execute an agreement with a transferee and may ultimately decide to terminate the Janssen Collaboration Agreement. Additionally, our ability to receive payments from this arrangement will depend in part on Janssen’s, or any third-party transferee’s, ability to successfully commercialize CD388.

The Janssen Collaboration Agreement poses many risks to us, including that our collaborator, Janssen:

•has significant discretion in determining the efforts and resources it will apply to developing, manufacturing, registering and commercializing CD388;

•may terminate the collaboration agreement at will, subject to certain limitations;

•may be subject to changes in key personnel or strategic focus, have limited available funding or be subject to other external factors diverting resources or creates competing priorities, all of which could negatively impact the development, manufacturing, registration and commercialization of CD388;

•may independently develop, or develop with third parties, products that compete directly or indirectly with CD388 if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

•may not agree with certain development decisions resulting in the delay or termination of the program, or that result in costly litigation or arbitration that diverts management attention and resources;

•could be involved in a business combination and the continued pursuit and emphasis on CD388 could be delayed, diminished or terminated; and

•could be financially impacted by ~~the COVID-19 pandemic.~~inflation or bank failures.

If our ability to generate revenue under the Janssen Collaboration Agreement is adversely impacted by these or any other risks, our right to receive additional payments under the Janssen Collaboration Agreement, including milestone payments and royalties on tiers of annual net sales at rates from the mid-single digits to the high-single digits, could be insufficient to allow us to achieve or maintain profitability or may result in CD388 being less valuable to us than if we had not entered into the Janssen Collaboration Agreement.

We may seek to selectively establish other collaborations and, if we are unable to establish them on commercially reasonable terms or at all, we may have to alter our research, clinical development and commercialization plans.*

We may seek to collaborate with other pharmaceutical and biotechnology companies to advance the Cloudbreak program for DFCs outside the scope of the Janssen Collaboration Agreement, or for the completion of development and commercialization of rezafungin in Japan. We may also seek funding from government grants or contracts to advance the Cloudbreak program for DFCs outside of the Janssen Collaboration Agreement. We cannot be certain that we will be successful in completing any such collaboration or obtaining any such government grants or contracts, or completing any of them on commercially reasonable terms.

We face significant competition in seeking appropriate pharmaceutical or biotech collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, on the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.

Those factors may include:

•the design or results of preclinical studies, chemistry, manufacturing and controls, or CMC, development activities or clinical trials;

•the likelihood of approval by the FDA or similar regulatory authorities outside the U.S.;

•the potential market for the product candidate in the territories that are the subject of the collaboration;

•the costs and complexities of manufacturing and delivering such product candidate to patients;

•the potential of competing products;

•the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge; and

•industry and market conditions generally.

The collaborator may also consider alternative product candidates for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidate.

We also face significant competition for government grants and contracts for the Cloudbreak program, and there can be no assurances that such funding would be available to us if and when needed, or at all. For instance, government funding may be available only at certain phases of research and development, such as only after Phase 1 clinical trials have been completed. In order to advance the Cloudbreak program for DFCs outside of the Janssen Collaboration Agreement, we will need to obtain significant funding to complete IND-enabling studies, manufacturing development and Phase 1 clinical trials. Government grants and contracts may not be available to fund our activities at this earlier phase of the research and development process.

We intend to continue to rely on third parties to conduct our clinical trials and to conduct some aspects of our research and preclinical testing and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.*

We currently rely and expect to continue to rely on third parties, such as CROs, contract manufacturers of clinical supplies, clinical data management organizations, medical institutions and clinical investigators, to conduct our clinical trials and to conduct some aspects of our research and preclinical testing. Many of these third parties may terminate their

engagements with us at any time. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If we need to enter into alternative arrangements, it would delay our product development activities.

Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA and other international regulatory authorities require us to comply with standards, commonly referred to as Good Clinical Practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, available at www.clinicaltrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

In addition, the ability of these third parties to conduct certain of their operations, including monitoring of clinical sites, may be limited by the COVID-19 pandemic, and to the extent that such third parties are unable to fulfil their contractual obligations as a result of the COVID-19 pandemic or government orders in response to the pandemic, we may have limited or no recourse under the terms of our contractual agreements with such third parties. Further, if any of the third parties with whom we engage were to experience shutdowns or other substantial disruptions due to the COVID-19 pandemic, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively affected, which could have a material adverse impact on our business and our results of operation and financial condition.

We have no experience manufacturing product candidates on a clinical or commercial scale and will be dependent on third parties for the manufacture of our product candidates. If we experience problems with any of these third parties, they could delay clinical development or marketing approval of our product candidates or our ability to sell any approved products.*

We do not have any manufacturing facilities. We currently rely, and expect to continue to rely, on third-party manufacturers for the manufacture of our product candidates for preclinical studies and clinical trials and for commercial supply of any of these product candidates should we obtain marketing approval.

We ~~may be unable to establish~~have established agreements with third-party manufacturers for ~~preclinical,~~production of our products for clinical orand commercial ~~supply on terms favorable to us, or at all. Even if we are able to establish agreements with third-party manufacturers,~~use, and our reliance on ~~third-party~~these- manufacturers entails additional risks, including:

•reliance on the third party for regulatory compliance and quality assurance;

•the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet quality standards or timelines; and

•the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

Third-party manufacturers may not be able to comply with current U.S. Good Manufacturing Practice requirements, or cGMPs, or similar regulatory requirements outside the U.S. Our failure, or the failure of our third-party manufacturers, to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product candidates or approved products, could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations.

Any product that we develop may compete with other product candidates and products for access to these manufacturing facilities. There are a limited number of manufacturers that operate under cGMPs and that might be capable of manufacturing for us.

Any performance failure on the part of our existing or future manufacturers, including a failure that may not relate specifically to our product candidate or approved product, ~~or a failure due to the COVID-19 pandemic,~~ could delay clinical development or marketing approval or adversely impact our ability to generate commercial sales. If any one of our current contract manufacturers cannot perform as agreed, we may be required to replace that manufacturer. Some of our third-party manufacturers which we use for the supply of materials for product candidates or other materials necessary to manufacture product to conduct preclinical tests and clinical trials are located in countries affected by COVID-19, and

~~should they experience disruptions, such as temporary closures or suspension of services, we would likely experience delays in advancing these tests and trials.~~

Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

We currently rely, and expect to continue to rely, on third parties to release, label, store and distribute drug supplies for our clinical trials. Any performance failure on the part of these third parties, including a failure that may not relate specifically to our product candidate or approved product, could delay or otherwise adversely impact clinical development or marketing approval of our product candidates or commercialization of our drugs, producing additional losses and depriving us of potential revenue.

Moreover, our manufacturers and suppliers may experience difficulties related to their overall businesses and financial stability, which could result in delays or interruptions of supply of our product candidates or approved products.

We do not have alternate manufacturing plans in place at this time. If we need to change to other manufacturers, the FDA and comparable foreign regulators may have to approve these manufacturers’ facilities and processes prior to our use, which would require new testing and compliance inspections. In addition, the new manufacturers would have to be educated in or independently develop the processes necessary for production. This would result in delays and costs, and in the case of approved products, the potential loss of revenue.

Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters

If we are unable to take full advantage of regulatory programs designed to expedite drug development or provide other incentives, our development programs may be adversely impacted.*

There are a number of incentive programs administered by the FDA and other regulatory bodies to facilitate development of drugs in areas of unmet medical need. In the U.S., rezafungin has been designated a Qualified Infectious Disease Product, or QIDP, a ~~fast track~~Fast Track product, and, with respect to the indication for treatment of candidemia and invasive candidiasis, rezafungin has also been designated as an orphan drug. In June 2023, CD388 also received Fast Track designation in the U.S. Our product candidates may not qualify for, or maintain, designations under these or other similar

incentive programs. For example, rezafungin may not receive orphan drug designation in the U.S. for the prophylaxis indication. Our inability to fully take advantage of these incentive programs may require us to run larger trials, incur delays, lose opportunities that may not otherwise be available to us, lose marketing exclusivity for which we would otherwise be eligible and incur greater expense in the development of our product candidates.

If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, our product candidates and our ability to generate revenue will be impaired.*

Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, release, safety, efficacy, regulatory filings, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the U.S. and by comparable authorities in other countries. For example, in order to commence clinical trials of our product candidates in the U.S., we must file an IND and obtain FDA agreement to proceed. The FDA may place our development program on clinical hold and require further preclinical testing prior to allowing our clinical trials to proceed.

We must obtain marketing approval in each jurisdiction in which we market our products. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. We have ~~not submitted a marketing application or received approval to market any of our product candidates from regulatory authorities in any jurisdiction. We have~~ only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party CROs to assist us in this process. As a company we may not be able to prepare our contract manufacturers and clinical sites for inspection associated with NDA review, or appearing before an FDA advisory committee. ~~Our NDA~~We may receive a Complete Response Letter rather than approval. Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each indication to establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process, testing and release and inspection of manufacturing facilities and personnel by the relevant regulatory authority. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

The process of obtaining marketing approvals, both in the U.S. and elsewhere, is expensive, may take many years and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. We cannot assure you that we will ever obtain any marketing approvals in any jurisdiction. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations or changes in regulatory review for each submitted product application may cause delays in the approval or rejection of an application. The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical or other studies, changes in the manufacturing process or facilities or clinical trials. Moreover, approval by the FDA or an equivalent foreign authority does not ensure approval by regulatory authorities in any other countries or jurisdictions, but a failure to obtain marketing approval in one jurisdiction may adversely impact the likelihood of approval in other jurisdictions. In addition, varying interpretations of the data obtained from preclinical testing, manufacturing and product testing and clinical trials could delay, limit or prevent marketing approval of a product candidate. Additionally, any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

The COVID-19 pandemic could also potentially affect the business of the FDA and comparable authorities in other countries, which could result in delays in meetings related to planned clinical trials and ultimately of reviews and approvals of our product candidates.

Any product candidate for which we obtain marketing approval could be subject to marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.

Any product candidate for which we obtain marketing approval, along with the manufacturing processes and facilities, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of promotional materials and safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements for product facilities, quality assurance and corresponding maintenance of records and documents and requirements regarding the distribution of samples to physicians and related recordkeeping. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure that they are marketed only for the approved indications and in accordance with the provisions of the approved labeling. However, companies may share truthful and not misleading information that is otherwise consistent with the product’s FDA approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we do not comply with these restrictions, we may be subject to enforcement actions.

In addition, later discovery of previously unknown problems with our products, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements, may result in, among other things:

•restrictions on such products, manufacturers or manufacturing processes or facilities;

•restrictions on the labeling, marketing, distribution or use of a product;

•requirements to conduct post-approval clinical trials, other studies or other post-approval commitments;

•warning or untitled letters;

•withdrawal of the products from the market;

•refusal to approve pending applications or supplements to approved applications that we submit;

•recall of products;

•fines, restitution or disgorgement of profits or revenue;

•suspension or withdrawal of marketing approvals;

•refusal to permit the import or export of our products;

•product seizure; and

•injunctions or the imposition of civil or criminal penalties.

Our relationships with customers, health care professionals and third-party payors may be subject to applicable healthcare laws, which could expose us to penalties, including administrative, civil or criminal penalties, damages, fines, imprisonment, exclusion from participation in federal healthcare programs such as Medicare and Medicaid, reputational harm, the curtailment or restructuring of our operations and diminished future profits and earnings.*

Healthcare professionals and third-party payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our current and future arrangements with customers, healthcare professionals and third-party payors may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we conduct research, market, sell and distribute our medicines for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations include the following, among others:

•the federal healthcare anti-kickback statute, which prohibits persons and entities from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;

•the federal false claims laws, which impose criminal and civil penalties, including civil whistleblower or qui tam actions under the federal civil False Claims Act, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

•the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective business associates and their covered subcontractors that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

•the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;

•the federal transparency requirements under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the Affordable Care Act, which require, among other things, certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and information regarding physician ownership and investment interests; and

•analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business activities, including sales or marketing arrangements and claims involving healthcare items or services including, in some states, those reimbursed by non-governmental third-party payors, including private insurers, some state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments or other transfers of value provided to physicians and other health care providers and entities, marketing expenditures, or drug pricing, state and local laws that require the registration of pharmaceutical sales representatives, and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Interpretations of standards of compliance under these laws and regulations are rapidly changing and subject to varying interpretations and it is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other laws that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, reputational harm, imprisonment, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of our

operations, any of which could diminish our future profits or earnings. If any of the physicians or other providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

If our information technology systems or ~~sensitive information,~~data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including, but not limited to, regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; ~~loss of customers or sales;~~ and other adverse consequences.*

In the ordinary course of our business, we and the third parties upon which we rely, may collect, store, use, transmit, receive, generate, transfer, disclose, make accessible, protect, secure, dispose of, process, and share ~~and otherwise process~~(collectively, processing) sensitive information, including personal data, proprietary and confidential business data, trade secrets, intellectual property, data we collect about trial participants in connection with clinical trials, and sensitive third-party data (collectively, sensitive ~~information)~~data). ~~We are dependent upon our own or third-party information technology systems, infrastructure~~As a result, we and ~~sensitive information, including mobile technologies, to operate our business. Our ability to monitor these third parties’ information security practices is limited, and these~~the third parties ~~may~~upon which we rely face a variety of evolving threats, including but not ~~have adequate information~~limited to ransomware attacks, which could cause security measures in place. The secure collection, storage, use, transmission and processing of such information is vital to our operations and business strategy. Any actual or perceived breach of our security measures or those of our third-party service providers, consultants, or contractors could adversely affect our business, operations, financial condition, and future prospects.incidents.

Cyberattacks, malicious internet-based activity, ~~and~~ online and offline fraud, ~~are prevalent~~ and ~~continue to increase. These threats are becoming increasingly difficult to detect. The procedures~~other similar activities threaten the confidentiality, integrity, and ~~controls we use to monitor cybersecurity threats~~availability of our sensitive data and ~~mitigate our exposure to such threats may not be sufficient to prevent security incidents, and our internal~~ information technology systems, and those of ~~our third-party service providers, consultants,~~the third parties upon which we rely. Such threats are prevalent and ~~contractors~~continue to rise, are ~~potentially vulnerable~~increasingly difficult to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war, public health crises (such as the COVID-19 global pandemic), telecommunicationdetect, and ~~electrical failures, theft as well as security incidents from inadvertent or intentional actions. These threats~~ come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors.

Some actors now engage and are expected to continue to engage in cyberattacks, including without limitation, nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks, including retaliatory cyberattacks that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products.

We and the third parties upon which we rely ~~may be~~are subject to ~~additional~~a variety of evolving threats, including, but not limited to, ~~the deployment of harmful~~social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), ~~ransomware, viruses, worms,~~ denial-of-service attacks, ~~(such as~~ credential ~~stuffing), supply chain~~stuffing attacks, ~~social engineering schemes (including through phishing attacks)~~credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, earthquakes, fires, floods, attacks enhanced or facilitated by artificial intelligence, or AI, and other means to affect service reliability and threaten the confidentiality, integrity and availability of sensitive information, which may compromise our, or our third-party service providers’, consultants’, or contractors’ system infrastructure or lead to data leakage or misdirected payments to and from us. Ransomwaresimilar threats.

In particular, severe ransomware attacks ~~including those from organized criminal threat actors, nation-states and nation-state supported actors,~~ are becoming increasingly prevalent ~~and severe~~ and can lead to significant interruptions ~~delays, or outages~~ in our operations, ability to provide our products or services, loss of sensitive data ~~loss of~~and income, ~~significant extra expenses to restore data or systems,~~ reputational ~~loss~~harm, and ~~the~~ diversion of funds. ToExtortion payments may alleviate the ~~financial, operational and reputational~~negative impact of a ransomware attack, ~~it may be preferable to make extortion payments,~~ but we may be unwilling or unable to ~~do so (including,~~make such payments due to, for example, if applicable laws or regulations ~~prohibit~~prohibiting such ~~payments). Similarly, supply chain attacks have increased in frequency~~payments.

Remote work has become more common and severity, and we cannot guarantee that third parties and infrastructure in our supply chain have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our platform, systems and networks or the systems and networks of third parties that support us and our services. Despite the security controls we have in place, such attacks are very difficult to avoid. Moreover, the prevalent use of mobile devices that access sensitive information increases the risk of security incidents. Additionally, the COVID-19 pandemic and our remote workforce poseshas increased risks to our information technology systems and data, as more of our employees ~~work from home, utilizing~~utilize network connections, computers, and devices outside our ~~premises. Future~~premises or network, including

working at home, while in transit, and in public locations. Additionally, future or past business transactions (such as acquisitions or integrations) could ~~also~~ expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information technology environment and security program.

In addition, our reliance on third-party service providers could introduce new cybersecurity risks and vulnerabilities, including supply-chain attacks, and other threats to our business operations. We rely on third-party service providers and technologies to operate critical business systems to process sensitive data in a variety of contexts, including, without limitation, CROs, contract manufacturers of clinical and commercial supplies, clinical data management organizations, medical institutions, clinical investigators, cloud-based infrastructure, data center facilities, encryption and authentication technology, employee email, and other functions. We also rely on third-party service providers to provide other products, services, parts, or otherwise to operate our business. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If our third-party service providers experience a security incident or other interruption, we could experience adverse consequences. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award. In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised.

Any of the previously identified or similar threats could cause a security incident or other ~~interruption.A security incident or other~~ interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive ~~information.~~data or our information technology systems, or those of the third parties upon whom we rely. A security incident or other interruption could disrupt our ability (and that of third parties upon whom we rely) to manufacture or deliver our products.

~~We are also required to comply with laws, rules, industry standards and regulations, policies and contracts that may require us to maintain the security of sensitive information.~~ We may expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against security incidents. Additionally, certain data privacy and security obligations may require us to implement and maintain specific security measures or industry-standard or reasonable security measures to protect our information technology systems and sensitive data.

While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. We ~~may be unable in the future~~take steps to detect and remediate vulnerabilities, ~~in our information technology systems~~but we may not be able to detect and remediate all vulnerabilities because ~~such~~the threats and techniques used to exploit the vulnerability change frequently and are often sophisticated in ~~nature, and~~nature. Therefore, such vulnerabilities could be exploited but may not be detected until after a security incident has occurred. ~~Despite~~Unremediated high risk or critical vulnerabilities pose material risks to our ~~efforts to identify and remediate vulnerabilities, if any, in our information technology systems, our efforts may not be successful.~~business. Further, we may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities.

Applicable data privacy and security ~~laws, privacy policies and other data privacy and security~~ obligations may require us to notify relevant stakeholders of security incidents. Such disclosures are costly, and the ~~disclosures~~disclosure or the failure to comply with such requirements could lead to adverse consequences.

If we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may ~~also~~ experience adverse ~~consequences. These~~ consequences, ~~may include:~~such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive ~~information~~data (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other similar harms.

~~In addition, we~~ Security incidents and attendant consequences may ~~not have adequate insurance coverage for security incidents, including fines, judgments, settlements, penalties, costs, attorney fees~~negatively impact our ability to grow and other impacts that arise out of incidents or breaches. We cannot assure you that any insurance coverage will adequately cover liabilities actually incurred or that insurance will continue to be available to us on economically reasonable terms, or at all. The successful assertion of one or more large claims against us that exceeds our available insurance coverage, or results in changes to our insurance policies (including premium increases or the imposition of large deductible or co-insurance requirements), could have an adverse effect onoperate our business. ~~Additionally, our~~

Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. ~~Our risks are likely~~We cannot be sure that our insurance coverage will be adequate or sufficient to ~~increase as we~~protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to ~~expand, grow~~be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive data about us from public sources, data brokers, or other means that reveals competitively sensitive details about our ~~customer base,~~organization and ~~process, store, and transmit increasingly large amounts~~could be used to undermine our competitive advantage or market position. Additionally, sensitive data of ~~confidential, proprietary and sensitive information.~~the Company could be leaked, disclosed, or revealed as a result of or in connection with our employee’s, personnel’s, or vendor’s use of generative AI technologies.

We are subject to stringent and ~~changing~~evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; ~~litigation;~~litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; ~~loss of customers or sales;~~ and other adverse business consequences.*

In the ordinary course of business, we process sensitive ~~information, including personal~~ data, ~~proprietary~~ and ~~confidential business data, trade secrets, intellectual property, data~~as a result, we ~~collect about trial participants in connection with clinical trials, and sensitive third-party data. Our data processing activities~~may be subject us to numerous data privacy and security obligations, such as various ~~foreign and domestic~~ laws, regulations, guidance, industry standards, external and internal privacy and security policies, ~~contracts,~~contractual requirements, and other obligations ~~that govern the processing of personal~~relating to data ~~by us~~privacy and ~~on our behalf.~~security.

In the ~~United States,~~U.S., federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, ~~and~~ consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, HIPAA, as amended by HITECH, and their respective implementing regulations, impose requirements relating to the privacy, security and transmission of individually identifiable health information. Such laws may apply to us, our customers or our service providers. Most healthcare providers in the U.S., including institutions from which we may obtain customer data, are subject to data privacy and security regulations promulgated under HIPAA, as amended by HITECH. A person may be prosecuted for alleged HIPAA violations either directly or indirectly, such as under aiding-and-abetting or conspiracy principles. Consequently, depending on the facts and circumstances, we could face substantial civil and criminal penalties and liabilities if we knowingly receive individually identifiable health information from a HIPAA-covered healthcare provider that has not satisfied HIPAA’s requirements for disclosure of individually identifiable health information.

Additionally, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020, or CPRA, collectively CCPA, ~~which took effect on January 1, 2020, gives~~applies to personal information of consumers, business representatives, and employees who are California residents, ~~expanded~~and requires businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights, ~~to access and delete their personal data, opt out of certain personal data sharing, and receive detailed information about how their personal data is used.~~such as those noted below. The CCPA ~~also~~ provides for ~~civil penalties for violations (up~~administrative fines of up to $7,500 per ~~violation)~~violation and ~~contains a~~allows private ~~right of action for~~litigants affected by certain data breaches ~~that is expected~~ to ~~increase litigation.~~recover significant statutory damages. Although the CCPA exempts some data processed in the context of clinical trials, the CCPA ~~may increase our~~increases compliance costs and potential liability with respect to other personal data we maintain about California residents. In addition, ~~it is anticipated that the California Privacy Rights Act of 2020, or CPRA, which goes into effect on January 1, 2023 will expand the CCPA. Additionally,~~ the CPRA ~~establishes~~expanded the CCPA’s requirements, including by adding a new ~~California Privacy Protection Agency~~right for individuals to correct their personal information and establishing a new regulatory agency to implement and enforce the ~~CPRA, which could increase the risk of enforcement. Some observers have noted that the CCPA~~law. Other states, such as Virginia and ~~CPRA could mark~~

the beginning of a trend of states adopting more stringent privacy laws in the U.S., which could further increase our compliance costs, potential liability and adversely affect our business. For example, Virginia, Colorado, ~~Utah and Connecticut~~ have also passed comprehensive privacy laws, and similar laws are being considered in several other ~~states. In addition, data privacy and security laws have been proposed~~states, as well as at the federal ~~state,~~ and local ~~levels~~levels. These state laws and the CCPA provide individuals with certain rights concerning their personal information, including the right to access, correct, or delete certain personal information, and opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may impact our business and ability to provide our products and services. While these states, like the CCPA, also exempt some data processed in ~~recent years, which could~~the context of clinical trials, these developments may further complicate compliance ~~efforts. In addition, privacy advocates~~efforts, and ~~industry groups have proposed,~~increase legal risk and ~~may propose, standards with which~~compliance costs for us and the third parties upon whom we ~~are legally or contractually bound to comply.~~rely.

~~The global data protection landscape is also rapidly evolving, and we expect there will continue to be new and proposed~~Outside the U.S., an increasing number of laws, regulations, and industry standards ~~concerning~~govern data privacy ~~data protection,~~ and security. For example, the EU’s General Data Protection Regulation, or EU GDPR, the United Kingdom’s GDPR, or UK GDPR, and Brazil’s General Data Protection Law (Lei Geral de Proteção de Dados Pessoais, or LGPD) (Law No. 13,709/2018)~~, and China’s Personal Information Protection Law, or PIPL,~~ impose strict requirements for processing personal data. ~~We cannot yet determine the impact that such future laws, regulations~~

For example, under GDPR, companies may face temporary or definitive bans on data processing and standards may have on our business. The EU GDPR and UK GDPR impose stringent requirements and to date, have increased compliance burdens on us, including by mandating burdensome documentation requirements and granting certain rights to individuals to control how we collect, use, disclose, retain and process their personal data. EU member states may allow enact additional laws and regulations further limiting the processing of genetic, biometric or health data. Failure to comply with the requirements of the EU GDPR (or UK GDPR) and the applicable national data protection laws of the EU member states may result inother corrective actions; fines of up to ~~€20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. Further,~~20 million Euros under the EU GDPR, ~~also provides for~~17.5 million pounds sterling under the UK GDPR or, in each case, 4% of annual global revenue, whichever is greater; or private litigation related to ~~the~~ processing of personal data ~~that can be~~ brought by classes of data subjects or consumer protection organizations authorized at law to represent ~~the data subjects’~~their interests.

~~Certain jurisdictions have enacted~~We also conduct clinical trials in China and may be subject to new and emerging data ~~localization~~privacy regimes in China, including China’s Personal Information Protection Law, or PIPL, Cybersecurity Law, Data Security Law, Measures for Cybersecurity Review, Measures on the Security Assessment of Cross-border Data Transfer, and Measures for the Standard Contract on the Cross-border Transfer of Personal Information. In Canada, the Personal Information Protection and Electronic Documents Act, or PIPEDA, and various related provincial laws, ~~and cross-border personal data transfer laws, which could make it more difficult~~as well as Canada’s Anti-Spam Legislation, or CASL, may apply to our operations.

In addition, we may be unable to transfer personal data ~~across~~from Europe, China, and other jurisdictions ~~(such as transferring or receiving personal data that originates in~~to the ~~EU or in other foreign jurisdictions). For example, absent appropriate safeguards~~U.S. or other ~~circumstances, the EU GDPR generally restricts~~countries due to data localization requirements or limitations on cross-border data flows. Europe, China and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to ~~countries outside of~~other countries. In particular, the European Economic Area, or EEA, ~~that~~and the ~~European Commission does not consider to provide an adequate level of data privacy and security, such as~~United Kingdom, or UK, have significantly restricted the ~~U.S. These requirements apply not only to third-party transactions, but also to transfers~~transfer of personal data ~~within our company, including employee information. The European Commission recently adopted new Standard Contractual Clauses, or SCCs,~~to the U.S. and other countries whose privacy laws it generally believes are inadequate. China also requires entities to rely on a transfer mechanism to lawfully transfer personal data overseas and ensure that the overseas data recipients can meet the same data protection standards as required under the ~~EU GDPR for personal~~PIPL. Other jurisdictions may adopt similarly stringent interpretations of their data ~~transfers outside the EEA. Currently, these SCCs~~localization and cross-border data transfer laws. Although there are ~~a valid mechanism~~currently various mechanisms that may be used to transfer personal data ~~outside of~~from the ~~EEA. Additionally,~~EEA and UK to the ~~SCCs impose additional~~U.S. in compliance ~~burdens,~~with law, such as ~~conducting transfer impact assessments to determine whether additional security measures are necessary to protect~~ the ~~at-issue personal data. In addition, Switzerland~~EEA and UK’s standard contractual clauses, the UK’s International Data Transfer Agreement/Addendum, and the EU-U.S. Data Privacy Framework and the UK ~~similarly restrict~~extension thereto (which allows for transfers for relevant U.S.-based organizations who self-certify compliance and participate in the Framework), these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data ~~transfers outside of those~~to the U.S. If there is no lawful manner for us to transfer personal data from the EEA, the UK, or other jurisdictions to ~~countries such~~the

U.S., or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions (such as ~~the United States that do not provide an adequate level of personal data protection. If we cannot implement a valid compliance mechanism for cross-border data transfers, we may face~~Europe) at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other third parties, and injunctions against our processing or transferring of personal data ~~from Europe or other foreign jurisdictions. Loss of~~necessary to operate our ~~ability to~~business. Additionally, companies that transfer personal data ~~from Europe may reduce demand for our services from companies~~out of the EEA and UK to other jurisdictions, particularly to the U.S., are subject to increased scrutiny from regulators, individual litigants, and activities groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers of personal data ~~protection laws and may also require us to increase our data processing capabilities in those jurisdictions at significant expense. Moreover, other countries outside~~out of Europe ~~(e.g. China, Brazil) have enacted or are considering enacting similar~~for allegedly violating the GDPR’s cross-border data transfer ~~restrictions and laws requiring local data residency, which could increase the cost and complexity of delivering our services and operating our business.~~limitations.

In addition to data privacy and security laws, we may be contractually subject to ~~data privacy and security obligations, including~~ industry standards adopted by industry groups and may become subject to ~~new data privacy and security~~such obligations in the future. ~~For example, certain privacy laws, such as the GDPR and the CCPA, require our customers to impose specific~~We are also bound by other contractual ~~restrictions on their service providers.~~

We may publish privacy policies and other documentation regarding our collection, processing, use and disclosure of personal data. Although we endeavor to comply with our published policies and other documentation, we may at times fail to do so, or may be perceived to have failed to do so. Despite our efforts, we may not be successful in achieving compliance if our personnel, customers, or service providers fail to comply with our policies and documentation. Such failures can subject us to potential foreign, local, state and federal action if they are found to be deceptive, unfair, or misrepresentative of our actual practices.

~~Our~~ obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful.

Our employees and personnel may use generative AI technologies to perform their work, and the disclosure and use of personal information in generative AI technologies is subject to various privacy laws and other privacy obligations. Governments have passed and are likely to pass additional laws regulating generative AI. Any use of this technology could result in additional compliance costs, regulatory investigations and actions, and consumer lawsuits. If we are unable to use generative AI, it could make our business less efficient and result in competitive disadvantages.

We use AI and machine learning, or ML, to assist us in making certain decisions, which is regulated by certain privacy laws. Due to inaccuracies or flaws in the inputs, outputs, or logic of the AI/ML, the model could be biased and could lead us to make decisions that could bias certain individuals (or classes of individuals), and adversely impact their rights, employment, and ability to obtain certain pricing, products, services, or benefits.

We publish privacy policies, marketing materials, and other statements, such as compliance with certain certifications or self-regulatory principles, regarding data privacy and security. If these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, or other adverse consequences.

Obligations related to data privacy and security (and consumers’ data privacy expectations) are quickly changing, ~~in an~~becoming increasingly stringent, ~~fashion,~~and creating ~~some uncertainty as to the effective future legal framework.~~uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. ~~Compliance~~Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our services, information technologies, systems, and practices and to those of any ~~other applicable privacy and~~third parties that process personal data security laws and regulations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms to ensure compliance with the new data privacy and security rules. Although we endeavor to comply with all applicable data privacy and security obligations, weon our behalf.

We may at times fail (or be perceived to have failed) ~~to do so. Any failure or perceived failure by us, or third parties working on~~in our ~~behalf,~~efforts to comply with ~~applicable laws and regulations, any~~our data privacy and ~~data~~ security ~~obligations pursuant to contract, our stated privacy or security policies, or obligations to customers or other third parties may result in governmental enforcement actions~~

(including fines, penalties, judgments, settlements, imprisonment of company officials and public censure), civil claims, litigation, damage to our brand and reputation and loss of goodwill (both in relation to existing customers and prospective customers), any of which could have a material adverse effect on our business, operations and financial performance.obligations. Moreover, despite our efforts, our personnel or third parties ~~upon~~on whom we rely may fail to comply with such obligations, which could negatively impact our business ~~operations and compliance posture. For example, any failure by a third-party processor~~operations. If we or the third parties on which we rely fail, or are perceived to have failed, to address or comply with applicable ~~law, regulations,~~ data privacy and security obligations, we could face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims) and mass arbitration demands; additional reporting requirements and/or ~~contractual obligations~~oversight; bans on processing personal data; and orders to destroy or not use personal data. In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations. Any of these events could ~~result~~have a material adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers; interruptions or stoppages in ~~adverse effects, including~~our business operations (including, as relevant, clinical trials); inability to process personal data or ~~interruption~~to operate in ~~our~~certain jurisdictions (including in relation to clinical trials); limited ability to ~~operate~~develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or substantial changes to our business ~~and proceedings against us by governmental entities~~model or ~~others.~~operations.

We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, or FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators

from authorizing, promising, offering or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We may engage third parties for clinical trials outside of the U.S., to sell our products abroad once we enter a commercialization phase and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

The pharmaceutical industry in China is highly regulated and such regulations are subject to change which may affect approval and commercialization of our drugs.*

Currently, we conduct the ReSTORE trial in China and have exclusively licensed the rights to commercialize rezafungin, our investigational drug studied in the ReSTORE trial, in China to our third-party collaborator, Mundipharma. The pharmaceutical industry in China is subject to comprehensive government regulation and supervision, encompassing the approval, registration, manufacturing, packaging, licensing and marketing of new drugs. For example, in order to conduct a clinical trial in China, sponsors must not only obtain the approval of the National Medical Product Administration of China, but also a separate approval from or filing with the Ministry of Science and Technology under the Administrative Regulations on Human Genetic Resources of the ~~People's~~People’s Republic of China, or HGR Regulation, for clinical trials involving HGR Materials or Information. Any failure to comply with these requirements could cause our ReSTORE trial to be suspended by governing authorities, may result in fines and also may constitute a breach under our agreements with third parties assisting us in the conduct of the trial in China, such as our CRO. In recent years, the regulatory framework in China regarding the pharmaceutical industry has undergone significant changes, and we expect that it will continue to undergo significant changes. Certain changes or amendments to policy or law may result in increased compliance costs on our business or cause delays in the timely completion of the ReSTORE trial in China, or prevent the approval of rezafungin in China. Chinese authorities have become increasingly vigilant in enforcing laws in the pharmaceutical industry and any failure by us to maintain compliance with applicable laws and regulations or obtain and maintain required licenses and permits may result in the suspension or termination of our clinical activities in China.

Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.*

In the U.S. and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system, including cost-containment measures, that could reduce or limit coverage and reimbursement for newly approved drugs, prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

For example, in March 2010, President Obama signed into law the Affordable Care Act, a sweeping law intended to, among other things, broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance

remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. The Affordable Care Act and subsequent regulations revised the definition of “average manufacturer price” for reporting purposes, which could increase the amount of Medicaid drug rebates to states. However, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap for single source and innovator multiple source drugs, beginning January 1, 2024. Further, the Affordable Care Act imposed a significant annual fee on companies that manufacture or import branded prescription drug products. Substantial new provisions affecting compliance were also enacted under the Affordable Care Act, which may affect our business practices with healthcare practitioners. There have been executive, judicial and Congressional challenges to certain aspects of the Affordable Care Act. For example, legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act, or the Tax Act, included a provision which repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Affordable Care Act on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Moreover, prior to the U.S. Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the Affordable Care Act marketplace. The executive order also instructs certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the Affordable Care Act. Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program. It is possible that the Affordable Care Act will be subject to judicial or Congressional challenges in the future. It is unclear how any additional healthcare reform measures of the Biden administration will impact the Affordable Care Act and our business.

~~Legislative~~

In addition, legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

Further, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. In August 2011, the President signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments will remain in effect until ~~2031~~2032 unless additional ~~congressional~~Congressional action is taken. However, COVID-19 relief support legislation suspended the 2% Medicare sequester from May 1, 2020 through March 31, 2022. Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester. Additionally, in January 2013, the President signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

In addition, there have been several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drug products. In July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, the Department of Health and Human Services, or HHS, released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. In addition, the IRA, among other things, (1) directs HHS to negotiate the price of certain single-source drugs and biologics covered under Medicare and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions ~~will~~ take effect progressively starting in fiscal year 2023. On August 29, 2023, ~~although they may~~HHS announced the list of the first ten drugs that will be subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges. Under the new Drug Price Negotiation Program, the number of drugs subject to price negotiation will be 10 Part D drugs for 2026, another 15 Part D drugs for 2027, another 15 Part D and Part B drugs for 2028, and another 20 Part D and Part B drugs for 2029 and later years. These drugs will be selected from among the 50 drugs with the highest total Medicare Part D spending and the 50 drugs with the highest total Medicare Part B spending. The number of drugs with negotiated prices available will accumulate over time. The IRA permits HHS to implement many of the statutory provisions through guidance, as opposed to regulation, for the initial years. HHS has and will continue to issue and update guidance as these programs are implemented. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry. Further, in response to the Biden ~~administration released an additional~~administration’s October 2022 executive order, on ~~October~~February 14, ~~2022, directing~~2023, HHS ~~to submit~~released a report ~~within ninety (90) days on how~~outlining three new models for testing by the Center for Medicare and Medicaid Innovation ~~can~~which will be ~~further leveraged~~evaluated on their ability to ~~test new models for lowering drug costs for Medicare~~lower the cost of drugs, promote accessibility, and ~~Medicaid beneficiaries.~~improve quality of care. It is unclear whether ~~this executive order or similar policy initiatives~~the models will be ~~implemented~~utilized in any health reform measures in the future.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to

encourage importation from other countries and bulk purchasing. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

~~Further, it is possible that additional governmental action is taken in response to the COVID-19 pandemic.~~ We expect that additional healthcare reform measures will be adopted within and outside the U.S. in the future, any of which could add difficulty to the regulatory approval processes for our product candidates or limit the amounts that governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures. The continuing efforts of third-party payors to contain or reduce costs of healthcare may adversely affect the demand for any drug products for which we may obtain regulatory approval, our ability to set a price that we believe is fair for our products, our ability to obtain coverage and reimbursement approval for a product, our ability to generate revenues and achieve or maintain profitability and the level of taxes that we are required to pay.

Risks Related to Our Intellectual Property

If our efforts to protect the proprietary nature of the intellectual property related to rezafungin, CD388, CBO421, our other Cloudbreak compounds or our other product candidates or compounds are not adequate, we may not be able to compete effectively in our markets.*

We rely upon a combination of patents, trademarks, trade secret protection and confidentiality agreements to protect the intellectual property related to rezafungin and our other product candidates and compounds. Any involuntary disclosure to or misappropriation by third parties of our proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our markets.

The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain and our commercial success will depend on our ability to obtain patents and maintain adequate protection for rezafungin, our DFCs and other compounds and product candidates in the U.S. and other countries. We currently hold issued U.S. utility and foreign patents and multiple pending U.S. utility patent applications, pending U.S. provisional patent applications and pending international, foreign national and regional counterpart patent applications covering various aspects of rezafungin and our DFCs. The patent applications may fail to result in issued patents in the U.S. or in foreign countries or jurisdictions. Even if the applications do successfully issue, third parties may challenge the patents.

Further, the existing and/or future patents, if any, may be too narrow to prevent third parties from developing or designing around these patents. If the sufficiency of the breadth or strength of protection provided by the patent and patent applications we own with respect to rezafungin or our DFCs or the patents we pursue related to any of our other product candidates or compounds is threatened, it could dissuade companies from collaborating with us to develop and threaten our ability to commercialize the product candidates or compounds. Further, if we encounter delays in our clinical trials, the period of time during which we could market our product candidates under patent protection would be reduced, although a patent term extension or supplementary protection certificate having varied scope may be available in certain jurisdictions to compensate for some of the lost patent term. In addition, we do not know whether:

•we were the first to make the inventions covered by each of our pending patent applications or our issued patents;

•we were the first to file patent applications for these inventions;

•others will independently develop similar or alternative technologies or duplicate any of our technologies;

•any of our pending patent applications will result in issued patents;

•any of our patents, once issued, will be valid or enforceable or will issue with claims sufficient to protect our products, or will be challenged by third parties;

•any patents issued to us will provide us with any competitive advantages;

•we will develop additional proprietary technologies that are patentable; or

•the patents of others will have an adverse effect on our business.

In addition, patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. In September 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted and may also affect patent

litigation. The U.S. Patent and Trademark Office, or USPTO, developed new regulations and procedures to govern administration of the Leahy-Smith Act and many of the substantive changes to patent law associated with the Leahy-Smith Act and, in particular, the first to file provisions, only became effective in March 2013. The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition and prospects.

In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable in one or more jurisdictions, inventions for which patents are difficult to enforce and any other elements of our drug discovery program that involve proprietary know-how, information and technology that is not covered by patents. Although we require all of our employees, consultants, advisers and third parties who have access to our proprietary know-how, information and technology to enter into confidentiality agreements, we cannot be certain that this know-how, information and technology will not be disclosed or used in an unauthorized manner or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.

There also may be challenges or other disputes concerning the inventorship, ownership or right to use our intellectual property. For example, our consultants and advisors may have obligations to assign certain inventions and/or know-how that they develop to third-party entities in certain instances, and these third parties may challenge our ownership or other rights to our intellectual property, which would adversely affect our business.

An inability to obtain, enforce and defend patents covering our proprietary technologies would materially and adversely affect our business prospects and financial condition. Further, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the U.S. We may encounter significant problems in protecting, enforcing and defending our intellectual property both in the U.S. and abroad. If we are unable to prevent unauthorized material disclosure of the intellectual property related to our technologies to third parties or are otherwise unable to protect, enforce or defend our intellectual property, we will not be able to establish or, if established, maintain a competitive advantage in our markets, which could materially adversely affect our business, operating results and financial condition.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various foreign or jurisdictional governmental patent agencies in several stages over the lifetime of the patents and/or applications. We have systems in place to remind us to pay these fees, and we employ an outside firm to pay these fees due to foreign patent agencies. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.

We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. Such noncompliance events are outside of our direct control for (1) non-U.S. patents and patent applications owned by us and, (2) if applicable in the future, patents and patent applications licensed to us by another entity. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents with claims to materials, methods of manufacture or methods of treatment related to the use or manufacture of rezafungin, our DFCs and/or our other product candidates or compounds. If any third-party patents were held by a court of competent jurisdiction to cover the rezafungin or DFC manufacturing process, any molecules formed during these processes or the final products or any use thereof, the holders of any such patents may be able to block our ability to commercialize the product unless we obtained a license under the applicable patent or patents or until such patents expire. These same issues and risks arise in connection with any other product candidates we develop as well. We cannot predict whether we would be able to obtain a license on commercially reasonable terms, or at all. Any inability to obtain

such a license under the applicable patents on commercially reasonable terms, or at all, would have a material adverse effect on our ability to commercialize the affected product until such patents expire.

In addition, third parties may obtain patents in the future and claim that our product candidates and/or the use of our technologies infringes upon these patents. Furthermore, parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees in the case of willful infringement, obtain one or more licenses from third parties, pay royalties and/or redesign our infringing products, which may be impossible and/or require substantial time and monetary expenditure. In addition, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of one or more of our product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, or at all. In that event, we would not be able to further develop and commercialize such product candidates, which could harm our business significantly.

We may be required to file lawsuits or take other actions to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our current or future patents. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of our asserted patents is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly and could put our patent applications at risk of not issuing. Pursuit of these claims would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business.

Interference proceedings or derivative proceedings provoked by third parties or brought by the USPTO may be necessary to determine the entitlement to patent protection with respect to our patents or patent applications. An unfavorable outcome could result in a loss of our patent rights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms, or at all. Litigation or patent office proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent misappropriation of our trade secrets or confidential information, particularly in countries where the laws or legal process may not protect those rights as fully as in the U.S.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

Issued patents covering our product candidates and technologies could be found invalid or unenforceable if challenged in court or the USPTO.

If we initiate legal proceedings against a third party to enforce a patent covering one of our product candidates or our technologies, the defendant could counterclaim that the patent covering our product candidate or our technology, as applicable, is invalid and/or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates or our technologies. The outcome following legal assertions of invalidity and/or unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art or that prior art that was cited during prosecution, but not relied on by the patent examiner, will not be revisited. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection directed to our product candidates or technologies. Such a loss of patent rights could have a material adverse impact on our business.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involve both technological and legal complexity, and are therefore costly, time-consuming and inherently uncertain. In addition, the U.S. has implemented wide-ranging patent reform legislation, including patent office administrative proceedings that offer broad opportunities to third parties to challenge issued patents. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, the USPTO and foreign governmental bodies and tribunals, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. For example, in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held in 2013 that certain claims to DNA molecules are not patentable and lower courts have since been applying this case in the context of other types of biological subject matter. We cannot predict how future decisions by the courts, the U.S. Congress, the USPTO or foreign governmental bodies or tribunals may impact the value of our patent rights.

We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

We have limited intellectual property rights outside the U.S. Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive and our intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S. In addition, the laws and legal processes of some foreign countries do not protect intellectual property to the same extent as federal and state laws in the U.S. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S. or from selling or importing products made using our inventions in and into the U.S. or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and further, may export otherwise infringing products to territories where we have patents but enforcement is not as strong as that in the U.S. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions. The legal systems of certain countries, particularly China and certain other developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property, particularly those relating to pharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put any of our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. The requirements for patentability may differ in certain countries, particularly developing countries. Furthermore, generic drug manufacturers or other competitors may challenge the scope, validity or enforceability of any of our current or future patents, requiring us to engage in complex, lengthy and costly litigation or other proceedings. Certain countries in Europe and developing countries, including China and India, have

compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we may have limited remedies if any of our patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for name recognition by potential partners or customers in our markets of interest. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors, and academic or research institutions. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.

Risks Related to U.S. Government Contracts and Grants

If we are unable to generate revenues from partnerships, government funding or other sources of funding, we may be forced to suspend or terminate one or more of our preclinical Cloudbreak programs.

In order to continue our Cloudbreak programs for DFCs outside the scope of the Janssen Collaboration Agreement, we will need to seek funding from partnerships, the government or other sources of funding. There can be no assurances that we will be able to obtain funding from partnerships, or enter into new contracts with the U.S. government or obtain other sources of funding to support such programs. The process of completing a partnership or obtaining government contracts

is lengthy and uncertain and we will have to compete with other companies and institutions in each instance. Further, with respect to government contracting, changes in government budgets and agendas may result in a decreased and de-prioritized emphasis on supporting the discovery and development of anti-infective products. If we cannot obtain or maintain government or other funding for our Cloudbreak programs for DFCs outside the scope of the Janssen Collaboration Agreement, we may be forced to discontinue those programs.

Our use of government funding adds uncertainty to our research and commercialization efforts and may impose requirements that increase our costs.

Contracts funded by the U.S. government and its agencies include provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to:

•terminate agreements, in whole or in part, for any reason or no reason;

•reduce or modify the government’s obligations under such agreements without the consent of the other party;

•claim rights, including intellectual property rights, in products and data developed under such agreements;

•audit contract-related costs and fees, including allocated indirect costs;

•suspend the contractor from receiving new contracts pending resolution of alleged violations of procurement laws or regulations;

•impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;

•suspend or debar the contractor from doing future business with the government;

•control and potentially prohibit the export of products; and

•pursue criminal or civil remedies under the Federal Civil Monetary Penalties Act and the federal civil False Claims Act and similar remedy provisions specific to government agreements.

In addition, government contracts contain additional requirements that may increase our costs of doing business, reduce our profits and expose us to liability for failure to comply with these terms and conditions. These requirements include, for example:

•specialized accounting systems unique to government contracts;

•mandatory financial audits and potential liability for price adjustments or recoupment of government funds after such funds have been spent;

•public disclosures of certain contract information, which may enable competitors to gain insights into our research program; and

•mandatory socioeconomic compliance requirements, including labor standards, anti-human-trafficking, non-discrimination, and affirmative action programs and environmental compliance requirements.

If we fail to maintain compliance with these requirements, we may be subject to potential liability and to termination of our contracts.

Changes in funding for the FDA, the Securities and Exchange Commission, or SEC, and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including beginning on December 22, 2018 and ending on January 25, 2019, the U.S. government has shut down several times and certain regulatory authorities, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If repeated or prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could

have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Our business is subject to audit by the U.S. government and a negative audit could adversely affect our business.

U.S. government agencies routinely audit and investigate government contractors and recipients of Federal grants. These agencies review a contractor’s performance under its contracts, cost structure and compliance with applicable laws, regulations and standards.

Government agencies also review the adequacy of, and a contractor’s compliance with, its internal control systems and policies, including the contractor’s purchasing, property, estimating, compensation and management information systems. Any costs found to be improperly allocated to a specific contract will not be reimbursed, while such costs already reimbursed must be refunded.

If an audit uncovers improper or illegal activities, we may be subject to civil and criminal penalties and administrative sanctions, including:

•termination of contracts;

•forfeiture of profits;

•suspension of payments;

•fines; and

•suspension or prohibition from conducting business with the U.S. government.

In addition, we could suffer serious reputational harm if allegations of impropriety were made against us, which could cause our stock price to decrease.

Laws and regulations affecting government contracts make it more expensive and difficult for us to successfully conduct our business.

We must comply with numerous laws and regulations relating to the formation, administration and performance of government contracts, which can make it more difficult for us to retain our rights under our government grant contracts. These laws and regulations affect how we conduct business with government agencies. Among the most significant government contracting regulations that affect our business are:

•the Federal Acquisition Regulations, or FAR, and agency-specific regulations supplemental to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts;

•business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and include other requirements such as the Anti-Kickback Statute and Foreign Corrupt Practices Act;

•export and import control laws and regulations; and

•laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.

Any changes in applicable laws and regulations could restrict our ability to obtain new contracts, which could limit our ability to conduct our business and materially adversely affect our results of operations.

Risks Related to Employee Matters and Managing Growth

Our ability to manage our business operations, to execute our strategic plan and to recruit talented employees may be adversely impacted by COVID-19.*

Since early March 2020, we have taken precautionary measures intended to help minimize the risk of COVID-19 to our employees and their families. In accordance with state and federal guidelines, we have reduced those precautionary measures in 2022 and have permitted employees to return to the office, work remotely, or adopt hybrid schedules based on job responsibilities. Further measures may be taken as the COVID-19 outbreak continues. These measures could negatively affect our business. For instance, remote work may disrupt our operations, limit our ability to interact with and effectively manage our third-party manufacturers CROs or current and planned clinical trial sites. The measures taken now or in the future to contain the COVID-19 pandemic could negatively affect our ability to recruit and engage new employees and contractors necessary to the successful operation of our business.

~~Our~~ future success depends on our ability to retain our senior management team and to attract, retain and motivate qualified personnel.

We are highly dependent upon our senior management team, as well as the other principal members of our research and development teams. All of our executive officers are employed “at will,” meaning we or they may terminate the employment relationship at any time. We do not maintain “key person” insurance for any of our executives or employees. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.

Recruiting and retaining qualified scientific, clinical, manufacturing, regulatory, quality assurance and sales and marketing personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.

We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisers, including scientific, regulatory, quality assurance and clinical advisers, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisers may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

We expect to expand our operations, and may encounter difficulties in managing our growth, which could disrupt our business.

We expect to expand the scope of our operations, particularly in the areas of drug development, manufacturing, clinical, regulatory affairs, quality assurance and sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. We may not be able to effectively manage the expected expansion of our operations or recruit and train additional qualified personnel. Moreover, the expected expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.

In the future, we may enter into transactions to acquire other businesses, products or technologies and our ability to do so successfully is unproven. If we do identify suitable candidates, we may not be able to make such acquisitions on favorable terms, or at all. Any acquisitions we make may fail to strengthen our competitive position and these transactions may be viewed negatively by customers or investors. We may decide to incur debt in connection with an acquisition or issue our common stock or other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders. We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations into our existing business in an effective, timely and non-disruptive manner. Acquisitions may also divert management attention from day-to-day responsibilities, increase our expenses and reduce our cash available for operations and other uses. We cannot predict the number, timing or size of future acquisitions or the effect that any such transactions might have on our operating results.

Risks Related to Ownership of our Common Stock

The price of our stock may be volatile, and you could lose all or part of your investment.*

The trading price of our common stock is highly volatile and subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this report, these factors include:

•changes in the market valuations of similar companies;

•the commencement, timing, enrollment or results of the current and planned clinical trials of our product candidates or any future clinical trials we may conduct, or changes in the development status of our product candidates;

•any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter, ~~"complete response"~~“complete response” letter, or a request for additional information;

•adverse results, suspensions, terminations or delays in pre-clinical or clinical trials;

•our decision to initiate a clinical trial, not to initiate a clinical trial, or to terminate an existing clinical trial or development program;

•adverse regulatory decisions, including failure to receive regulatory approval of our product candidates;

•~~the impact of the COVID-19 pandemic on our business and industry as well as the global economy;~~

•changes in laws or regulations applicable to our products, including but not limited to requirements for approvals;

•changes in the structure of healthcare payment systems or limitations on the ability of hospitals and outpatient treatment centers to receive adequate reimbursement for the purchase and use of our products;

•adverse developments concerning our contract manufacturers;

•our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices or acceptable quality;

•our inability to establish collaborations, if needed;

•our failure to commercialize our product candidates successfully, or at all;

•additions or departures of key scientific or management personnel;

•unanticipated serious safety concerns related to the use of our product candidates;

•the introduction of new products or services offered by us or our competitors;

•announcements of significant acquisitions, strategic partnerships, joint ventures, government grants or contracts or capital commitments by us or our competitors;

•our ability to effectively manage our growth;

•the size and growth of our fungal infection, bacterial infection or other target markets;

•our ability to successfully enter new markets or develop additional product candidates;

•actual or anticipated variations in quarterly operating results;

•our cash position and our ability to raise additional capital and the manner and terms on which we raise it, and the expectation of future fundraising activities by us;

•our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

•publication of research reports or other media coverage about us or our industry or our therapeutic approaches in particular or positive or negative recommendations or withdrawal of research coverage by securities analysts;

•overall performance of the equity markets;

•sales of our common stock by us or our stockholders in the future or the expectation of such sales;

•the trading volume of our common stock;

•changes in accounting practices;

•ineffectiveness of our internal controls;

•disputes or other developments relating to proprietary rights, including patent rights, litigation matters and our ability to obtain patent protection for our technologies;

•significant lawsuits, including patent or stockholder litigation;

•general political and economic ~~conditions;~~conditions including the military conflict in Ukraine and Russia and bank failures; and

•other events or factors, many of which are beyond our control.

In addition, the stock market in general, and The Nasdaq Capital Market, pharmaceutical companies and companies in the anti-infective sector in particular, have experienced extreme price and volume fluctuations that may or may not have been related or proportionate to the operating performance of these companies or their product potential. Broad market and industry factors ~~such as the COVID-19 pandemic and actions taken to slow its spread,~~ may negatively affect the market price of our common stock, regardless of our actual operating performance. You may not realize any return on your investment in us and may lose some or all of your investment. In the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results or financial condition.

We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our stock.

We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the appreciation of their stock.

Our principal stockholders and management own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval.

Our executive officers, directors and 5% stockholders and their affiliates currently beneficially own a significant percentage of our outstanding voting stock. These stockholders have the ability to influence us through this ownership position. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents or approval of any merger, sale of

assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

We incur significant costs as a result of operating as a public company, and our management devotes substantial time to compliance initiatives.

As a public company, we incur significant legal, accounting and other expenses. We are subject to the reporting requirements of the Securities Exchange Act of 1934, which require, among other things, that we file with the SEC annual, quarterly and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and The Nasdaq Capital Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas such as “say on pay” and proxy access. Stockholder activism, the political environment and the level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.

We expect the rules and regulations applicable to public companies to continue to result in substantial legal and financial compliance costs and to make some activities more time-consuming and costly. If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse effect on our business, financial condition and results of operations. These costs could decrease our net income or increase our net loss and may require us to reduce costs in other areas of our business or increase the prices of our products or services. For example, these rules and regulations could make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.

If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate financial statements on a timely basis could be impaired and our public reporting may be unreliable.*

Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Based on our evaluation of the effectiveness of our internal control over financial reporting as of September 30, 2022, we determined that we had a material weakness as of September 30, 2022 because our review control over the evaluation of applicable accounting standards and assessment of completeness and accuracy of valuation assumptions, related to non-routine transactions that include collaboration revenue, was not appropriately designed or operating effectively. While this improper design and operation did not result in a material error in the annual or interim financial statements, there is a reasonable possibility that a material misstatement in the annual or interim financial statements would not have been detected. A material weakness, as defined in Rule 12b-2 under the Exchange Act, is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected on a timely basis.

We are in the process of implementing a remediation plan. We have amended our process to add additional layers of review by members of our management team regarding the evaluation of applicable accounting standards and completeness and accuracy of valuation assumptions related to non-routine transactions that include collaboration revenue. The effectiveness of our process changes and overall remediation efforts is being assessed by management on an ongoing basis. The remediation actions are also being monitored by the Audit Committee of our Board of Directors. However, we cannot assure you that these efforts will remediate this material weakness in a timely manner, or at all, or that we will be able to maintain effective controls and procedures even if we remediate this material weakness. If we are unable to successfully remediate this material weakness, design or operate effective controls and procedures, or identify any future material weaknesses, the accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports and we may experience a loss of public confidence, which could have an adverse effect on our business, financial condition and the market price of our common stock.

We are required to disclose changes made in our internal control procedures on a quarterly basis and our management is required to assess the effectiveness of these controls annually. However, for as long as we are a “non-accelerated filer,” our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur additional expenses of remediation. In addition, if we are unable to remediate this material weakness, or if we are otherwise unable to conclude that our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of our

financial reports, the market price of our securities could decline, and we could be subject to sanctions or investigations by The Nasdaq Capital Market, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.*

If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock could decline. We had ~~71,181,197~~90,415,944 shares of common stock outstanding as of September 30, ~~2022.~~2023. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.

Sales of our common stock by current stockholders may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate and may make it more difficult for you to sell shares of our common stock. In addition, shares of common stock that are either issuable upon the exercise of outstanding options or warrants or reserved for future issuance under our employee benefit plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144 and Rule 701 under the Securities Act. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.

Certain holders of our securities are entitled to rights with respect to the registration of their shares under the Securities Act. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates, as defined in Rule 144 under the Securities Act. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.

Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.

We believe, based on our current business plan, that our existing cash and cash equivalents will not be sufficient to fund our obligations for the twelve months following the filing of this report. Significant additional capital will be needed to continue our operations as currently planned, including conducting clinical trials, commercialization efforts, expanded research and development activities and costs associated with operating as a public company. To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities, new investors

could gain rights, preferences and privileges senior to our existing stockholders and our existing stockholders may be materially diluted by such subsequent sales.

Pursuant to our 2015 Equity Incentive Plan, or the 2015 EIP, our management is authorized to grant stock options to our employees, directors and consultants. The number of shares of our common stock reserved for issuance under the 2015 EIP will automatically increase on January 1 of each year through and including January 1, 2025, by 4% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year or a lesser number of shares determined by our board of directors. Additionally, the number of shares of our common stock reserved for issuance under our 2015 Employee Stock Purchase Plan, or the ESPP, will automatically increase on January 1 of each year through and including January 1, 2025, by the lesser of 1% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year or 490,336 shares. Unless our board of directors elects not to increase the number of shares available for future grant each year under the 2015 EIP and the ESPP, our stockholders may experience additional dilution, which could cause our stock price to fall.

We have broad discretion in the use of working capital and may not use it effectively.

Our management has broad discretion in the application of our working capital. Because of the number and variability of factors that determine our use of our working capital, its ultimate use may vary substantially from its currently intended use. Our management might not apply our working capital in ways that ultimately increase the value of your investment. We expect to use our working capital to fund research and development activities and general operating expenses. The failure by our management to apply this working capital effectively could harm our business. Pending its use, we may invest our working capital in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders. If we do not invest or apply our working capital in ways that enhance stockholder value, we may fail to achieve expected financial results, which could cause our stock price to decline.

Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.

Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:

•a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time;

•a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders;

•a requirement that special meetings of stockholders be called only by the chairman of the board of directors, the chief executive officer or by a majority of the total number of authorized directors;

•advance notice requirements for stockholder proposals and nominations for election to our board of directors;

•a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors;

•a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation; and

•the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock.

In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporate Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These anti-takeover provisions and other provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors and could also delay or impede a merger, tender offer or proxy contest involving our company. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing or cause us to take other corporate actions you desire. Any delay or prevention of a change of control transaction or changes in our board of directors could cause the market price of our common stock to decline.

Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that is governed by the internal affairs doctrine. This choice of forum provision does not apply to suits brought to enforce a duty or liability created by the Exchange Act, or any claim for which the federal courts have exclusive jurisdiction. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees. Alternatively, if a court were to find the choice of forum provision contained in our amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving such action in other jurisdictions, all of which could adversely affect our business and financial condition.

While the Delaware courts have determined that exclusive choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price may decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.*

Under current law, unused U.S. federal net operating losses generated in tax years beginning after December 31, 2017, will not expire and may be carried forward indefinitely, but the deductibility of such federal net operating losses ~~in taxable years beginning after December 31, 2020,~~ is limited to 80% of taxable income. It is uncertain if and to what extent various states will conform to federal tax laws. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. As a result of capital raising and other transactions that have occurred since our inception in 2012, we ~~may or may not~~ have ~~experienced an “ownership change.”~~identified several ownership changes that will impact our ability to utilize our net operating losses and credit carryforwards. We may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership. As of December 31, ~~2021,~~2022, we had U.S. federal net operating loss carryforwards of approximately ~~$306.8~~$185.3 million, portions of which will begin to expire in ~~2033,~~2035, and which could be limited if we experience an “ownership change.” In addition, at the state level, there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited. As a result, if we earn net taxable income, we may be unable to use all or a material portion of our net operating loss carryforwards and other tax attributes, which could potentially result in increased future tax liability to us and adversely affect our future cash flows.

Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.*

The tax regimes to which we are subject or under which we operate are unsettled and may be subject to significant change. The issuance of additional guidance related to existing or future tax laws, or changes to tax laws or regulations proposed or implemented by the current or a future U.S. presidential administration, Congress, or taxing authorities in other jurisdictions, including jurisdictions outside of the U.S., could materially affect our tax obligations and effective tax

rate. To the extent that such changes have a negative impact on us, including as a result of related uncertainty, these changes may adversely impact our business, financial condition, results of operations, and cash flows.

The amount of taxes we pay in different jurisdictions depends on the application of the tax laws of various jurisdictions, including the U.S., to our international business activities, tax rates, new or revised tax laws, or interpretations of tax laws and policies, and our ability to operate our business in a manner consistent with our corporate structure and intercompany arrangements. The taxing authorities of the jurisdictions in which we operate may challenge our methodologies for pricing intercompany transactions pursuant to our intercompany arrangements or disagree with our determinations as to the income and expenses attributable to specific jurisdictions. If such a challenge or disagreement were to occur, and our position was not sustained, we could be required to pay additional taxes, interest, and penalties, which could result in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall profitability of our operations. Our financial statements could fail to reflect adequate reserves to cover such a contingency. Similarly, a taxing authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a “permanent establishment” under international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions.

Effective January 1, 2022, the Tax Act eliminated the option to deduct research and development expenses for tax purposes in the year incurred and requires taxpayers to capitalize and subsequently amortize such expenses over five years for research activities conducted in the U.S. and over 15 years for research activities conducted outside the U.S. Although there have been legislative proposals to repeal or defer the capitalization requirement to later years, there can be no assurance that the provision will be repealed or otherwise modified. Future guidance from the Internal Revenue Service and other tax authorities with respect to such legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation.

Our business and operations would suffer in the event of system failures.

Despite the implementation of security measures, our internal computer systems and those of our contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any such system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and we may incur substantial costs to attempt to recover or reproduce the data. If any disruption or security breach resulted in a loss of or damage to our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability and/or the further development of our product candidates could be delayed.

Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity, public health crisis, pandemic diseases and other events beyond our control, the occurrence of which could materially harm our business.*

Businesses located in California have, in the past, been subject to electrical blackouts as a result of a shortage of available electrical power and any future blackouts could disrupt our operations. We are also vulnerable to a major earthquake, wildfire, inclement weather and other natural and man-made disasters and public health crisis and pandemic diseases, such as coronavirus, and we have not undertaken a systematic analysis of the potential consequences to our business as a result of any such natural disaster, public health crisis or pandemic diseases and do not have an applicable recovery plan in place. In addition, if any of our third-party contract manufacturers are affected by natural disasters, such as earthquakes, power shortages or outages, floods, wildfire, public health crises, such as pandemics and epidemics, terrorism or other events outside of our control, our business and operating results could suffer. For example, as a result of the COVID-19 pandemic, we ~~have~~ experienced significant disruptions in the conduct of our clinical trials and our general business operations as the result of various federal, state and local stay-at-home, shelter-in-place and quarantine measures. We carry only limited business interruption insurance that would compensate us for actual losses from interruption of our business that may occur and any losses or damages incurred by us in excess of insured amounts could cause our business to materially suffer.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

7784

ITEM 6. EXHIBITS


Exhibit						Description

3.1(1)						Amended and Restated Certificate of Incorporation of the Registrant, as currently in effect.

3.2(1)						Amended and Restated Bylaws of the Registrant, as currently in effect.

3.3(4)						Certificate of Designation of Preferences, Rights and Limitations of Series X Convertible Preferred Stock.

4.1(2)						Form of Common Stock Certificate of the Registrant.

4.2(3)						Form of Warrant to Purchase Common Stock issued to Pacific Western Bank.

4.3(4)						Form of Common Stock Purchase Warrant for First Private Placement.

10.1*						~~License Agreement~~ ~~by and between the Registrant and~~ ~~Melinta Therapeutics, LLC, dated~~ ~~July 26, 2022.~~

~~10.2+~~						~~Employment offer letter between the Registrant and Taylor Sandison, dated March 22, 2017.~~

~~10.3+~~						~~Employment offer letter between the Registrant and Shane M. Ward, dated August 17, 2021.~~

~~10.4+~~						~~Employment offer letter between the Registrant and Preetam Shah, dated August 19, 2021.~~

31.1						Certification of Principal Executive Officer required by Rule 13a-14(a) promulgated under the Securities Exchange Act of 1934, as amended.

31.2						Certification of Principal Financial Officer required by Rule 13a-14(a) promulgated under the Securities Exchange Act of 1934, as amended.

~~32.1~~32.1*						Certification of Principal Executive Officer required by Rule 13a-14(b) promulgated under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350.

~~32.2~~32.2*						Certification of Principal Financial Officer required by Rule 13a-14(b) promulgated under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350.

101.INS						Inline XBRL Instance Document.

101.SCH						Inline XBRL Taxonomy Extension Schema Document.

101.CAL						Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF						Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB						Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE						Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104						The cover page from the ~~Company's~~Company’s Quarterly Report on Form 10-Q has been formatted in Inline


+			~~Indicates management contract or compensatory plan.~~
*			Certain portions of this exhibit (indicated by asterisks) have been excluded pursuant to Item 601(b)(10) of Regulation S-K because they are both not material and are the type that the Registrant treats as private or confidential.
(1)			Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on April 24, 2015.
(2)			Incorporated by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-202740), as amended, originally filed with the SEC on March 13, 2015.
(3)			Incorporated by reference to the ~~Registrant's~~Registrant’s Current Report on Form 8-K, filed on October 3, 2016.
(4)			Incorporated by reference to the ~~Registrant's~~Registrant’s Current Report on Form 8-K, filed on May 21, 2018.
*			The certifications attached as Exhibits 32.1 and 32.2 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

7885

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	Cidara Therapeutics, Inc.

Date: November ~~3, 2022~~2, 2023	By:	/s/ Jeffrey Stein, Ph.D.
		Jeffrey Stein, Ph.D.
		President and Chief Executive Officer
		(Principal Executive Officer)

Date: November ~~3, 2022~~2, 2023	By:	/s/ Preetam Shah, Ph.D., MBA
		Preetam Shah, Ph.D., MBA
		Chief Financial Officer and Chief Business Officer
		(Principal Financial Officer and Principal Accounting Officer)

7986


	Three Months Ended September 30, 2021						Nine Months Ended September 30, 2021
	Mundipharma		Janssen		Melinta		Mundipharma		Janssen		Melinta
Revenue from Collaboration and License Agreements:
Point in Time:
License of Intellectual Property	$	—	$	—	$	—	$	—	$	27,000	$	—
Clinical Drug Supply	—		—		—		—		—		—
Over Time:
Research and Development Services	3,033		2,072		—		7,795		3,747		—
Clinical Supply Services	237		1,734		—		598		3,207		—
Total Revenue from Collaboration and License Agreements	$	3,270	$	3,806	$	—	$	8,393	$	33,954	$	—